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Viking Therapeutics

Latest FDA Approval News

Bristol-Myers Squibb: U.S. Food and Drug Administration Approves Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a Treatment for Patients with Previously Untreated Microsatellite Instability-High or Mismatch Repair Deficient Unresectable

April 8
Last Trade: 53.07 -2.12 -3.84

Based on the Phase 3 CheckMate-8HW trial, Opdivo plus Yervoy demonstrated reduction in the risk of disease progression or death by 79% vs. chemotherapy in the first-line setting and by 38% vs. Opdivo monotherapy across all lines of therapy 1 The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date PRINCETON, N.J. / Apr 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today...Read more


Amgen: UPLIZNA® (inebilizumab-cdon) Is Now The First And Only FDA-Approved Treatment For IgG4-related Disease

April 3
Last Trade: 280.26 -9.43 -3.26

Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo  UPLIZNA Shown to Deliver Corticosteroid-Free, Flare-Free, Complete Remission for Patients in the MITIGATE Trial Advances Amgen's Leadership in CD19 Directed, B-Cell Depletion Therapies for Serious Autoimmune Diseases Including NMOSD, IgG4-RD and gMG THOUSAND OAKS, Calif., April 3, 2025 /PRNewswire/ -- Amgen...Read more


Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)

April 2
Last Trade: 101.96 -0.91 -0.88

Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program1 Phase III data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at Week 6 and sustained through Week 36 and favorable safety1,2 IgAN is a progressive, rare kidney disease; up to 50% of patients with persistent...Read more


Revvity Secures FDA Approval for Improved Automated Latent Tuberculosis Test

April 2
Last Trade: 91.79 -4.37 -4.54

FDA approves leading solution for latent tuberculosis diagnostics, advancing global effort to fight infectious diseases WALTHAM, Mass. / Apr 02, 2025 / Business Wire / Revvity, Inc. (NYSE: RVTY), today announced that the U.S. Food and Drug Administration (FDA) has approved the Auto-Pure 2400 liquid handling platform with the T-SPOT™.TB test. Initially launched outside the U.S. in 2024, this powerful combination allows laboratories to...Read more


AstraZeneca: IMFINZI® (durvalumab) approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer

March 31
Last Trade: 64.90 -0.89 -1.35

Based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Mar 31, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been...Read more


Alnylam Pharmaceuticals: FDA Approves Qfitlia™ (fitusiran), the First siRNA (RNAi Therapeutic) for the Treatment of Hemophilia A or B

March 28
Last Trade: 230.19 -2.76 -1.18

Qfitlia Becomes the Sixth Alnylam-Discovered RNAi Therapeutic Approved by U.S. FDA and First and Only to Treat Hemophilia A or B With or Without Inhibitors CAMBRIDGE, Mass. / Mar 28, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today highlighted the significance of the U.S. Food and Drug Administration’s (FDA) approval of Qfitlia™ (fitusiran), the sixth Alnylam-discovered...Read more


Soleno Therapeutics Announces U.S. FDA Approval of VYKATTM XR to Treat Hyperphagia in Prader-Willi Syndrome

March 26
Last Trade: 59.04 -10.60 -15.22

First approved therapy to address hyperphagia in individuals with Prader-Willi syndrome Management to host conference call and webcast today, March 26th, at 5:30pm ET REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has...Read more


Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors

March 26
Last Trade: 34.13 -0.71 -2.04

FDA approval based on the phase 3 CABINET pivotal trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus placebo  CABOMETYX is now the first and only systemic treatment that is FDA approved for previously treated neuroendocrine tumors regardless of primary tumor site, grade, somatostatin receptor expression and functional status  Exelixis is prepared to...Read more


GSK: Blujepa (gepotidacin) Approved by US FDA for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) in Female Adults and Pediatric Patients 12 Years of Age and Older

March 25
Last Trade: 34.13 -0.71 -2.04

Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years Over half of all women experience a uUTI in their lifetime, with approximately 30% suffering from a recurrent episode Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials PHILADELPHIA / Mar 25, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa...Read more


Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy

March 25
Last Trade: 1.55 -0.09 -5.49

New, improved formulation set to replace EGRIFTA SV® MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The...Read more


Tenon Medical Announces FDA Clearance of Catamaran(R) SI Joint Fusion System for New Indication to Augment Spinal Fusion

March 24
Last Trade: 1.09 -0.07 -6.03

Achieves Significant Milestone with Expanded Use Indication, Opens Sizable New SI Market Opportunity  LOS GATOS, CA / ACCESS Newswire / March 24, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of an expanded indication for...Read more


Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)

March 20
Last Trade: 101.96 -0.91 -0.88

Phase III study showed sustained proteinuria reduction at one year with favorable safety1 Fabhalta is the only oral alternative complement pathway inhibitor thought to target the underlying cause of C3G1-3 C3G is an ultra-rare kidney disease typically diagnosed in young adults and often progresses to kidney failure2-4 Novartis continues to advance multiple kidney disease treatments with high unmet need, compounding capabilities and...Read more


Alnylam Pharmaceuticals Announces FDA Approval of AMVUTTRA® (vutrisiran), the First RNAi Therapeutic to Reduce Cardiovascular Death, Hospitalizations and Urgent Heart Failure Visits in Adults with ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

March 20
Last Trade: 230.19 -2.76 -1.18

Novel Mechanism of Action Delivers Rapid Knockdown of Transthyretin, Addressing the Disease at its Source Proven Consistency of Effect on Cardiovascular Outcomes, Function, and Quality of Life in ATTR-CM Population Representative of Today’s Patients Only Therapeutic Approved in the U.S. to Address Both Cardiomyopathy and Polyneuropathy Manifestations of ATTR Amyloidosis Alnylam Offers Multiple Programs to Support Broad and Seamless...Read more


Johnson & Johnson: U.S. FDA approves TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease

March 20
Last Trade: 150.00 -0.62 -0.41

TREMFYA® is the only IL-23i to demonstrate clinical remission and endoscopic response, both at one year, with a fully subcutaneous induction regimen Supported by data from the GALAXI study, TREMFYA® is the only IL-23i to show superiority versus STELARA® in all pooled endoscopic endpoints within a double-blinded registrational trial  TREMFYA® approval in Crohn's disease builds upon recent ulcerative colitis FDA approval,...Read more


ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label

March 14
Last Trade: 63.05 -3.94 -5.88

ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to diabetic macular edema (DME) ANI plans to begin marketing ILUVIEN in the U.S. under the combined label later this year BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration...Read more


ANI Pharmaceuticals Announces FDA Approval of New Purified Cortrophin Gel® Prefilled Syringe

March 3
Last Trade: 63.05 -3.94 -5.88

PRINCETON, N.J., March 03, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in a prefilled syringe format. This new presentation will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established...Read more


FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults

March 3
Last Trade: 35.90 -0.10 -0.28

TNKase® (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, TNKase and Activase® (alteplase) SOUTH SAN FRANCISCO, Calif. / Mar 03, 2025 / Business Wire / Genentech, a member of the Roche Group (SIX:...Read more


Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's

February 24
Last Trade: 81.88 -1.27 -1.53

New closed-loop system self-adjusts DBS therapy to individual brain activity in real time; the largest commercial launch of brain-computer interface technology ever  GALWAY, Ireland, Feb. 24, 2025 /PRNewswire/ -- For the one million people diagnosed with Parkinson's disease in the United States1, Medtronic plc (NYSE:MDT), a global leader in healthcare technology, proudly announces U.S. Food and Drug Administration...Read more


Mirum Pharmaceuticals’ CTEXLI™ (chenodiol) Tablets Receives FDA Approval for Treatment of Cerebrotendinous Xanthomatosis (CTX)

February 24
Last Trade: 39.32 -1.68 -4.10

CTEXLI is the first and only medication approved for the treatment of CTX in adults Approval based on Phase 3 RESTORE study results CTEXLI granted U.S. FDA Orphan Drug exclusivity for the treatment of CTX FOSTER CITY, Calif. / Feb 24, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI™ (chenodiol) tablets, a bile acid, for the...Read more


Amneal Pharmaceuticals Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide

February 19
Last Trade: 6.99 -0.22 -3.05

Mesalamine 800 mg delayed-release tablets, referencing ASACOL HD® Lenalidomide capsules, referencing REVLIMID® BRIDGEWATER, N.J. / Feb 19, 2025 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in...Read more


PENMENVY, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY

February 17
Last Trade: 34.13 -0.71 -2.04

Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y) Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults PHILADELPHIA / Feb 17, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved PENMENVY (Meningococcal Groups...Read more


Evolus Announces FDA Approval of Evolysse™ Form and Evolysse™ Smooth Injectable Hyaluronic Acid Gels

February 13
Last Trade: 9.36 -0.88 -8.59

First Major Technological Breakthrough in Hyaluronic Acid Dermal Fillers in a Decade; U.S. Launch Planned in Q2 2025 Launch Establishes Evolus as a Multi-Product Performance Beauty Company and Expands Addressable Market by 78% NEWPORT BEACH, Calif. / Feb 13, 2025 / Business Wire / Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio, today announced that the U.S. Food and Drug...Read more


U.S. FDA Approves Pfizer’s ADCETRIS® Combination Regimen for the treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

February 12
Last Trade: 21.84 -0.79 -3.49

Approval is based on positive data from the Phase 3 ECHELON-3 trial, which demonstrated ADCETRIS regimen reduced the risk of death by 37%, a statistically significant, clinically meaningful improvement in overall survival (OS), compared to lenalidomide and rituximab plus placebo ECHELON-3 is the first Phase 3 trial to demonstrate OS advantage over lenalidomide and rituximab plus placebo for patients with at least 2 prior lines of...Read more


FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)

February 12
Last Trade: 35.90 -0.10 -0.28

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration SOUTH SAN FRANCISCO, Calif. / Feb 12, 2025 / Business Wire /...Read more


SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN 

February 11
Last Trade: 35.71 -1.28 -3.46

GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN  Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR, deep and durable reductions in tumor volume, and a manageable safety profile  SpringWorks granted rare pediatric disease priority review voucher by the FDA  STAMFORD, Conn., Feb. 11, 2025 (GLOBE NEWSWIRE) --...Read more


AbbVie: U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options

February 7
Last Trade: 175.67 -28.41 -13.92

EMBLAVEOTM is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the U.S. FDA to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria Gram-negative bacterial infections represent a significant public health threat due to their ability to develop resistance to antimicrobial therapies Antimicrobial resistance (AMR) could lead to over 39 million deaths...Read more


Supernus Pharmaceuticals Announces FDA Approval of ONAPGO™ (apomorphine hydrochloride) for Parkinson’s Disease

February 4
Last Trade: 30.64 -1.63 -5.05

ONAPGO is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease ONAPGO is a wearable subcutaneous infusion device that provides continuous treatment during the waking day for more consistent control of OFF time ONAPGO will be available in the U.S. in second quarter 2025 ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus...Read more


FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness

February 4
Last Trade: 35.90 -0.10 -0.28

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) With as few as two treatments per year, Susvimo may help people with DME maintain their vision Approval marks the second indication for Susvimo in addition to wet, or neovascular age-related macular degeneration (AMD) SOUTH SAN FRANCISCO, Calif. / Feb 04, 2025 / Business Wire /...Read more


Vertex Pharmaceuticals Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain

January 30
Last Trade: 472.37 -2.19 -0.46

JOURNAVX is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years JOURNAVX is an effective and well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain BOSTON / Jan 30, 2025 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food...Read more


Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults

January 30
Last Trade: 97.55 -0.95 -0.96

A single oral dose of SYMBRAVO provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours 85% and 77% of patients treated with a single dose of SYMBRAVO did not require migraine rescue medication within 24 hours in two Phase 3 studies SYMBRAVO demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe), and in...Read more


AstraZeneca: ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US as first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies

January 27
Last Trade: 64.90 -0.89 -1.35

Based on DESTINY-Breast06 Phase III trial results which showed ENHERTU demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year Approval brings AstraZeneca and Daiichi Sankyo’s ENHERTU to an earlier HR-positive treatment setting and broadens the patient population eligible for treatment with a HER2-directed therapy to those with HER2-ultralow disease WILMINGTON, Del. / Jan 27, 2025 /...Read more


Amneal Pharmaceuticals Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin

January 23
Last Trade: 6.99 -0.22 -3.05

Approval of three important therapies for dementia, oncology and gastrointestinal disease Granted 180-day exclusivity for memantine/donepezil extended-release capsules Tentative approval of rifaximin, a product for treating IBS-D BRIDGEWATER, N.J. / Jan 23, 2025 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved...Read more


Medexus Pharmaceuticals Announces FDA Approval of GRAFAPEX (treosulfan) for Injection and Provides Business Update

January 22
Last Trade: 2.04 -0.13 -5.99

Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed US$100 million within five years after commercial launch Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - January 22, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to provide a business update regarding the successful completion of the regulatory review process for GRAFAPEX™ (treosulfan) for...Read more


AstraZeneca: DATROWAY® (datopotamab deruxtecan-dlnk) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

January 17
Last Trade: 64.90 -0.89 -1.35

First approval in the US for AstraZeneca and Daiichi Sankyo’s DATROWAY based on TROPION-Breast01 results showing 37% reduction in the risk of disease progression or death vs. chemotherapy DATROWAY is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030 WILMINGTON, Del. / Jan 17, 2025 / Business Wire / DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with...Read more


Amgen: FDA Approves Lumakras® (Sotorasib) in Combination with Vectibix® (Panitumumab) for Chemorefractory Kras G12C-Mutated Metastatic Colorectal Cancer

January 17
Last Trade: 280.26 -9.43 -3.26

Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC THOUSAND OAKS, Calif., Jan. 17, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as...Read more


AstraZeneca: CALQUENCE® (acalabrutinib) plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma

January 17
Last Trade: 64.90 -0.89 -1.35

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone First and only BTK inhibitor approved for the 1st-line treatment of MCL in the US WILMINGTON, Del. / Jan 17, 2025 / Business Wire / AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with...Read more


Incyte and Syndax Pharmaceuticals Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo™ (axatilimab-csfr) 9 mg and 22 mg Vial Sizes

January 15
Last Trade: 10.56 -0.45 -4.09

U.S. launch expected in early February Niktimvo is the first and only approved treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis Pivotal data from the AGAVE-201 trial supporting FDA approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups WILMINGTON, Del. and WALTHAM, Mass., Jan. 15, 2025 /PRNewswire/ -- Incyte (Nasdaq:INCY)...Read more


FDA approves Eli Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease

January 15
Last Trade: 720.90 -2.84 -0.39

In the pivotal Phase 3 VIVID-1 trial, patients treated with Omvoh experienced significant improvement in clinical remission and endoscopic response at one year Among those who achieved clinical remission and endoscopic response at one year, nearly 90% of patients maintained clinical remission with two years of continuous Omvoh treatment in open-label extension INDIANAPOLIS, Jan. 15, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE:...Read more


Bristol-Myers Squibb: U.S. Food and Drug Administration Approves Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection, for Subcutaneous Use in Most Previously Approved Adult, Solid Tumor Opdivo® (nivolumab) Indications1,2

December 27
Last Trade: 53.07 -2.12 -3.84

Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor1 Given over three- to five-minutes, Opdivo Qvantig demonstrated consistent efficacy and showed a comparable safety profile to intravenous Opdivo in the Phase 3 CheckMate-67T trial1,3 PRINCETON, N.J. / Dec 27, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo...Read more


BeiGene: TEVIMBRA Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with Chemotherapy

December 27
Last Trade: 184.71 0.00 0.00

New indication based on results from a global Phase 3 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival for patients with advanced gastric cancers Second FDA approval for TEVIMBRA in 2024 SAN MATEO, Calif. / Dec 27, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the...Read more


AVITA Medical Announces FDA Approval of RECELL GO mini, Optimizing Treatment for Smaller Wounds

December 23
Last Trade: 7.67 -0.09 -1.16

VALENCIA, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO® mini. As a line extension of the RECELL GO system, the RECELL GO mini disposable...Read more


U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer

December 20
Last Trade: 21.84 -0.79 -3.49

BRAFTOVI in combination with cetuximab and mFOLFOX6 is the first and only combination regimen with targeted therapy approved for use as early as first-line for patients with metastatic colorectal cancer with a BRAF V600E mutation Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the Phase 3 BREAKWATER trial NEW YORK / Dec 20, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that...Read more


Eli Lilly: FDA approves Zepbound® (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity

December 20
Last Trade: 720.90 -2.84 -0.39

 Averaging up to 20% of weight loss, adults taking Zepbound had at least 25 fewer breathing interruptions each hour as they slept Up to 50% of adults taking Zepbound no longer had symptoms associated with OSA after one year INDIANAPOLIS, Dec. 20, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription...Read more


Vertex Pharmaceuticals Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis

December 20
Last Trade: 472.37 -2.19 -0.46

ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV1 and further decreased sweat chloride compared to TRIKAFTA® BOSTON / Dec 20, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug...Read more


Vertex Pharmaceuticals Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants

December 20
Last Trade: 472.37 -2.19 -0.46

Approximately 300 more people with cystic fibrosis in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time BOSTON / Dec 20, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with...Read more


Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients as Young as 2 Years Old

December 20
Last Trade: 57.73 2.77 5.04

BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to include children as young as 2 years old. IMCIVREE is indicated to reduce excess...Read more


Merit Medical Systems Announces FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis

December 20
Last Trade: 88.48 -4.03 -4.36

Unique cell-impermeable1 design extends life-saving treatment for dialysis patients Merit to host a WRAPSODY informational call on January 28, 2025 SOUTH JORDAN, Utah, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today that the WRAPSODY® Cell-Impermeable Endoprosthesis has received premarket approval from the US Food and...Read more


Humacyte Announces FDA Approval of SYMVESS™ (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma

December 19
Last Trade: 1.16 -0.10 -7.94

SYMVESS is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair In clinical testing SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection Highly experienced sales team already recruited and trained in preparation for commercial launch DURHAM, N.C., Dec. 19, 2024 (GLOBE NEWSWIRE) --...Read more


Ionis Pharmaceuticals: TRYNGOLZA™ (olezarsen) approved in U.S. as first-ever treatment for adults living with familial chylomicronemia syndrome as an adjunct to diet

December 19
Last Trade: 25.51 -2.06 -7.47

TRYNGOLZA shown to significantly reduce triglycerides and substantially reduce acute pancreatitis events in adults with FCS; a rare, highly debilitating and life-threatening disease Indicated for adults with FCS regardless of genetically or clinically confirmed diagnosis  TRYNGOLZA is the first of four independent launches planned over the next three years, pending approvals Ionis to host webcast today at 6:45pm ET...Read more


Mesoblast’s RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy

December 18
Last Trade: 10.03 -0.37 -3.56

RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication. RYONCIL is the first FDA-approved therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates. In a single-arm, multi-center, Phase 3 trial of children with SR-aGvHD, 89% of whom had high severity Grade C or...Read more


Organon: FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

December 16
Last Trade: 11.65 -0.87 -6.95

EFFICACY: In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on VTAMA cream achieved vIGA-AD™ treatment success at Week 8 versus 18% of patients on vehicle. POWERFUL SKIN CLEARANCE: The majority of patients entered with or achieved complete disease clearance (vIGA-AD=0) at least once in the 48-week open-label ADORING long-term extension (LTE) study and remained treatment-free (remittive effect) for an average of ~80...Read more


Neurocrine Biosciences Announces FDA Approval of CRENESSITY™ (crinecerfont), a First-in-Class Treatment for Children and Adults With Classic Congenital Adrenal Hyperplasia

December 13
Last Trade: 87.54 -5.71 -6.12

CRENESSITY, the first new treatment available in 70 years to the classic congenital adrenal hyperplasia (CAH) community, offers a paradigm-shifting treatment approach FDA approval supported by data from the largest-ever clinical trial program in pediatric and adult patients with classic CAH CRENESSITY is expected to be commercially available in approximately one week Rare Pediatric Disease Priority Review Voucher granted in...Read more


Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT™ (cosibelimab-ipdl)

December 13
Last Trade: 3.95 -0.04 -1.00

WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only...Read more


AstraZeneca: IMFINZI® (durvalumab) approved in the US as first and only immunotherapy regimen for patients with limited-stage small cell lung cancer

December 5
Last Trade: 64.90 -0.89 -1.35

Based on ADRIATIC Phase III trial results which showed a 27% reduction in the risk of death versus placebo WILMINGTON, Del. / Dec 05, 2024 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted...Read more


Merus Announces FDA Approval of BIZENGRI® (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer (NSCLC) Based on Safety and Efficacy Data From the eNRGy Study

December 4
Last Trade: 34.89 -2.50 -6.69

BIZENGRI® is the first and only therapy approved by the FDA specifically for pancreatic adenocarcinoma and NSCLC that harbor NRG1 gene fusions and are advanced unresectable or metastatic1 Merus and Partner Therapeutics announced a license agreement for U.S. commercialization UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) [Merus, the Company, we, or our], a clinical-stage...Read more


Zimmer Biomet Receives FDA Approval for Oxford® Cementless Partial Knee, Only Cementless Partial Knee Replacement Implant in the U.S.

November 25
Last Trade: 102.79 -2.05 -1.96

WARSAW, Ind., Nov. 25, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) Premarket Approval Application (PMA) Supplement approval for the Oxford® Cementless Partial Knee. The approval is based on safety and effectiveness data from an Investigational Device Exemption (IDE) study and non-clinical testing for...Read more


Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA

November 25
Last Trade: 35.90 -0.10 -0.28

The PATHWAY HER2 (4B5) test helps to identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA. There are currently very few options for BTC patients as most cases are at an advanced stage at the time of diagnosis. This approval represents a new indication for Roche's existing PATHWAY HER2 (4B5) test and expands its...Read more


BridgeBio Pharma: Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related Hospitalization in ATTR-CM Patients

November 22
Last Trade: 30.14 -0.53 -1.73

Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes Attruby demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date: In as few as 3 months, the time to first event (all-cause mortality (ACM)...Read more


Amneal Pharmaceuticals Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist

November 21
Last Trade: 6.99 -0.22 -3.05

Potential first and only DHE autoinjector for tough-to-treat migraines and cluster headaches Exenatide approval highlights Amneal’s capabilities in developing GLP-1 injectables BRIDGEWATER, N.J. / Nov 21, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to...Read more


FDA Approves Novocure’s Innovative HFE Transducer Arrays for Use With Optune Gio® for Glioblastoma

November 21
Last Trade: 15.37 -1.24 -7.47

New flexible arrays are lighter, thinner and designed to improve comfort for Optune Gio users ROOT, Switzerland / Nov 21, 2024 / Business Wire / Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) approved its new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio® for the treatment of adult patients with glioblastoma multiforme (GBM). Optune Gio is a wearable, portable device...Read more


Zymeworks: FDA Grants U.S. Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)

November 21
Last Trade: 9.91 -0.52 -4.99

Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial $25M milestone payment to be received from Jazz Pharmaceuticals in relation to the FDA...Read more


Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)

November 20
Last Trade: 102.82 -4.11 -3.84

Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial Company to host investor webcast on Dec. 11, 2024 For U.S. media and investors only DUBLIN, Nov....Read more


Syndax Pharmaceuticals Announces FDA Approval of Revuforj® (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation

November 15
Last Trade: 10.56 -0.45 -4.09

Approval based on positive data from the AUGMENT-101 clinical trial, in which Revuforj delivered robust and durable rates of remission in R/R acute leukemia patients with a KMT2A translocation Syndax to host conference call today at 6:00 p.m. ET WALTHAM, Mass., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the...Read more


PTC Therapeutics Announces FDA Approval of AADC Deficiency Gene Therapy

November 13
Last Trade: 39.77 -3.05 -7.12

First-ever FDA approval for gene therapy directly administered to the brain Priority review voucher granted Broad label including children and adults PTC pioneers new approach for CNS drug delivery WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the...Read more


Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

November 8
Last Trade: 1.18 -0.13 -9.92

AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy) Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALL Conference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) --...Read more


Journey Medical Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea

November 4
Last Trade: 6.10 -0.86 -12.36

SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release...Read more


Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile

October 29
Last Trade: 101.96 -0.91 -0.88

Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies1-3 Patients on Scemblix also had fewer dose reductions and half the rate of adverse reactions leading to treatment discontinuation1-3 Nearly 50% of CML patients do not meet efficacy milestones (MMR) with current SoC and almost 25% discontinue...Read more


Grifols Receives FDA Approval to Treat Surgical Bleeding in Pediatric Patients With its Fibrin Sealant Solution

October 29
Last Trade: 6.49 -0.06 -0.92

Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasis Grifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global...Read more


Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

October 25
Last Trade: 1.11 0.00 0.00

ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades Company to Host Conference Call on Monday, October 28th at 8:30 a.m. EDT DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™...Read more


ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Gel, 0.06%

October 25
Last Trade: 63.05 -3.94 -5.88

PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Estradiol Gel, 0.06%. ANI’s Estradiol Gel, 0.06% is the generic version of the reference listed drug (RLD) EstroGel® Gel, 0.06%. "With the FDA approval and...Read more


A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter

October 24
Last Trade: 81.88 -1.27 -1.53

First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter Highly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve Now with two pulsed field ablation (PFA) offerings and a portfolio of electrophysiology solutions, Medtronic is shaping the future of arrythmia treatment today GALWAY,...Read more


U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease

October 22
Last Trade: 21.84 -0.79 -3.49

First and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50 Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower respiratory tract disease caused by RSV NEW YORK / Oct 22, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO® (Respiratory Syncytial Virus Vaccine), the company’s bivalent...Read more


Alvotech and Teva Pharmaceutical Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab)

October 22
Last Trade: 13.59 -0.35 -2.51

Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn’s disease and ulcerative colitis The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024 SELARSDI’s U.S. launch for all indications is expected in Q1 2025 REYKJAVIK, Iceland & PARSIPPANY, N.J., Oct. 22, 2024...Read more


Amneal Pharmaceuticals Receives U.S. FDA Approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets

October 21
Last Trade: 6.99 -0.22 -3.05

Pyridostigmine Bromide Extended Release is a once-daily soman nerve agent pretreatment pyridostigmine product for the U.S. Armed Services and U.S. allies developed utilizing Amneal’s GRANDE® drug delivery technology Developed with the support of Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) BRIDGEWATER, N.J. / Oct 21, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq:...Read more


BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands)

October 18
Last Trade: 175.67 -28.41 -13.92

The Only Product of Its Kind Approved for Use in Four Aesthetic Indications: Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines, Frown Lines, Crow's Feet Lines, and Now Platysma Bands in Adults1-5 With this Approval, BOTOX® Cosmetic is the First and Only Aesthetic Neurotoxin Product to Temporarily Improve the Appearance of Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) in...Read more


Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY

October 18
Last Trade: 35.90 -0.10 -0.28

The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option. CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy. As the leader in companion diagnostics, Roche continues to build on its commitment...Read more


Avadel Pharmaceuticals Announces FDA Approval of LUMRYZ™ (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with Narcolepsy

October 17
Last Trade: 6.59 -0.10 -1.49

LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to...Read more


AbbVie: U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease

October 17
Last Trade: 175.67 -28.41 -13.92

VYALEV™ is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease Adults treated with VYALEV reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa1 VYALEV allows for personalized dosing based on individual needs, morning, day and night NORTH CHICAGO, Ill.,...Read more


FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer

October 15
Last Trade: 15.37 -1.24 -7.47

The first treatment of its kind for metastatic NSCLC, Optune Lua is approved for use concurrently with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who progressed on or after a platinum-based regimen Results of the pivotal Phase 3 LUNAR trial represent the first substantial improvement in median overall survival in more than 8 years for this patient population Optune Lua is a wearable treatment that...Read more


Bausch + Lomb Receives FDA Approval for enVista® Envy™ Full Range of Vision Intraocular Lens

October 14
Last Trade: 11.00 -0.87 -7.33

VAUGHAN, Ontario / Oct 14, 2024 / Business Wire / Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that the U.S. Food and Drug Administration has approved the enVista® Envy™ full range of vision intraocular lens (IOL), which offers a continuous range of vision with excellent dysphotopsia tolerance on the widely used enVista IOL...Read more


U.S. FDA Approves Pfizer’s HYMPAVZI™ (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors

October 11
Last Trade: 21.84 -0.79 -3.49

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis and on-demand treatment in eligible patients with hemophilia A or B without inhibitors In the U.S., HYMPAVZI is the first once-weekly subcutaneous prophylactic treatment for eligible people living with hemophilia B, and the first to be administered via a pre-filled pen or syringe for eligible people living with...Read more


Roche: FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

October 10
Last Trade: 35.90 -0.10 -0.28

Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting  This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis  Itovebi is...Read more


FDA Approves Use of Up To Three Tubes of Biofrontera’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment

October 7
Last Trade: 0.67 -0.05 -6.81

Approval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lamp Supplemental New Drug Application (sNDA) supported by two Phase 1 safety studies AK is the second most common diagnosis made by dermatologists in the United States1 An estimated 13 million treatments given each year for AK in the US2 WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) --...Read more


Elanco Animal Health Receives FDA Approval for Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), the Broadest(i) Canine Oral Parasiticide Protection in a Single Monthly Dose

October 7
Last Trade: 8.33 -0.61 -6.82

Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is the first and only canine oral parasiticide to protect against six parasites, including fleas, ticks, heartworms, roundworms, hookwormsii and three different species of tapeworm that other brands skip creating a gap in coverageiii Warming temperatures and changing consumer habits have increased parasite pressure and spread across geographies,...Read more


FDA Approves Exact Sciences’ Cologuard Plus Test, Setting a New Benchmark in Non-Invasive Colorectal Cancer Screening

October 4
Last Trade: 40.31 -3.52 -8.03

Cologuard Plus™ test raises the performance bar with sensitivities of 95% for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity Cologuard Plus test will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test Company expects to launch Cologuard Plus test with Medicare coverage and guideline inclusion in 2025 MADISON, Wis. / Oct 04, 2024 / Business Wire /...Read more


Bristol-Myers Squibb: U.S. Food and Drug Administration Approves Perioperative Treatment of Neoadjuvant Opdivo® (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable Non-Small Cell Lung Cancer (NSCLC)

October 3
Last Trade: 53.07 -2.12 -3.84

Approval is based on the CheckMate-77T trial, in which the Opdivo-based regimen demonstrated significantly longer event-free survival compared to the chemotherapy and placebo arm; a high pathologic complete response rate was also observed1 Opdivo is the only approved PD-1 inhibitor for resectable NSCLC in both a neoadjuvant-only regimen and as part of a perioperative treatment regimen1 This milestone adds to Bristol Myers Squibb’s...Read more


GE HealthCare announces FDA approval of Flyrcado (flurpiridaz F 18) injection PET radiotracer for enhanced diagnosis of coronary artery disease

September 27
Last Trade: 58.75 -2.24 -3.67

GE HealthCare’s FDA-approved flurpiridaz F 18 PET radiotracer, Flyrcado, delivers higher diagnostic efficacy in patients with known or suspected coronary artery disease (CAD), compared to SPECT MPI, the predominant procedure used in nuclear cardiology today With a half-life over ten times longer than currently approved cardiac PET radiotracers, Flyrcado brings the first practical opportunity to combine exercise stress testing with...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD

September 27
Last Trade: 556.81 -15.97 -2.79

Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and...Read more


PureTech-Invented KarXT Receives U.S. Food and Drug Administration Approval for the Treatment of Schizophrenia in Adults

September 27
Last Trade: 15.22 -2.08 -12.02

Milestone triggers payments to PureTech totaling $29 million under agreements with Royalty Pharma and PureTech’s Founded Entity, Karuna Therapeutics, which was acquired by Bristol Myers Squibb in March 2024, and unlocks potential future payments related to additional milestones and royalties Bristol Myers Squibb to market KarXT as CobenfyTM1 Cobenfy is the first new drug mechanism approved in over 50 years for the treatment of...Read more


U.S. Food and Drug Administration Approves Bristol Myers Squibb’s COBENFY™ (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of Schizophrenia in Adults

September 26
Last Trade: 53.07 -2.12 -3.84

COBENFY represents the first new pharmacological approach to treat schizophrenia in decades, with a mechanism of action distinct from current therapies Approval is supported by data from the EMERGENT clinical program demonstrating statistically significant reductions of schizophrenia symptoms The safety and tolerability profile of COBENFY has been established across acute and long-term trials in schizophrenia PRINCETON, N.J. / Sep...Read more


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Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...

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