First and only therapy FDA approved in both R/R acute myeloid leukemia (AML) with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation Second approved indication for Revuforj in less than one year further solidifies Syndax’s leadership in menin inhibition Included in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for R/R NPM1 mutated AML Syndax to host conference call today at 2:30 p.m. ET NEW YORK,...Read more
This approval is supported by data from the Phase III OASIS clinical trial program evaluating Lynkuet for the treatment of moderate to severe hot flashes due to menopause1 In OASIS 1 and OASIS 2, Lynkuet met the co-primary endpoints of reduction in number and severity of moderate to severe hot flashes day and night at weeks 4 and 12 from baseline1 Hot flashes are a common symptom of menopause2 and one of the main reasons women seek...Read more
Significant unmet need for patients requires new and novel treatments1 DREAMM-7 showed a 51% reduction in the risk of death and tripled median progression-free survival in 3L+ indicated population versus a daratumumab-based triplet2 Blenrep is the only anti-BCMA accessible in the community setting where 70% of patients receive care, and with a new streamlined REMS program3 Robust clinical development is ongoing to advance Blenrep in...Read more
FDA approval based on superiority of Gazyva over standard therapy alone, as shown in Phase II NOBILITY and Phase III REGENCY data Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomized Phase III study Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of color and childbearing age, with up to one third of patients...Read more
Updated indication allows the use of RINVOQ® (upadacitinib) prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug...Read more
FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.1 UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults.1 This approval marks a significant step...Read more
Second-generation delivery device offers cost-effective alternative to hospital care benefiting patients, providers, and payors Lasix ONYU is the 17th Captisol-enabled™ approved product JUPITER, Fla., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide...Read more
Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), the primary endpoint of the trial Libtayo is the current standard of care in advanced CSCC; approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y.,...Read more
ZORYVE cream 0.05% provides rapid and effective relief of mild to moderate atopic dermatitis in children ages 2 to 5 and is safe and well tolerated Once-daily, steroid-free cream can be used anywhere on the body for any duration About 1.8 million children ages 2 to 5 with atopic dermatitis are topically treated in the U.S. Sixth FDA approval for ZORYVE in just over three years Commercial product expected to be available by the end...Read more
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal Phase 3 IMforte trial Zepzelca and atezolizumab combination added to National Comprehensive Cancer Network® Guidelines for SCLC For U.S. media and investors only DUBLIN, Oct. 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for...Read more
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal Phase III IMforte study First and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLC Regimen recommended in National Comprehensive Cancer Network® Guidelines for SCLC* SOUTH SAN FRANCISCO, Calif. / Oct 02, 2025 / Business Wire /...Read more
Rhapsido helps to inhibit release of histamine and proinflammatory mediators by targeting BTK, offering unique approach to CSU treatment1 Well-controlled disease observed as fast as two weeks, with demonstrated safety profile that requires no lab monitoring1 1.7 million people in US live with CSU; more than half remain symptomatic despite increasing doses of antihistamines2,3 Remibrutinib also in clinical development for chronic...Read more
With new label, Dectomax®-CA1 Injectable is the first and only parasite control product with conditional approval to help control economically devastating pest Cochliomyia hominivorax (New World screwworm) PARSIPPANY, N.J. / Sep 30, 2025 / Business Wire / Zoetis Inc. today announced that Dectomax®-CA1 Injectable is the first and only parasite control product to receive conditional approval from the U.S. Food and Drug Administration for...Read more
This marks the second FDA-approved indication for Guardant360 CDx as a companion diagnostic in breast cancer treatment ESR1 mutations are present in 40% of HR+, HER2- advanced breast cancers PALO ALTO, Calif. / Sep 29, 2025 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Guardant360® CDx as a companion...Read more
TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six years and older, weighing at least 40 kg Approval was based on PROTOSTAR study, which showed pediatric patients receiving TREMFYA® achieved high levels of skin clearance vs. placebo at Week 16 HORSHAM, Pa., Sept. 29, 2025...Read more
FDA approval extends the indication of Evkeeza to treat younger patients with homozygous hypercholesterolemia (HoFH) HoFH is an inherited condition characterized by extremely high levels of low-density lipoprotein cholesterol (LDL-C) Initial Evkeeza approval based on placebo-controlled trial showing Evkeeza, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need...Read more
Novel nonpeptide SST2 agonist PALSONIFY advances the treatment paradigm as the first once-daily, oral therapy approved by the FDA to treat acromegaly Approval based on data from two pivotal Phase 3 trials where PALSONIFY was well tolerated and resulted in rapid, durable, and consistent biochemical control and reduced symptom burden Launch of lead product PALSONIFY marks a pivotal milestone for Crinetics as the premier...Read more
An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor In the Phase 3 EMBER-3 trial, Inluriyo monotherapy reduced the risk of progression or death by 38% versus endocrine therapy among patients with ESR1-mutated MBC INDIANAPOLIS, Sept. 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and...Read more
FDA now concludes "the totality of evidence supports removal of the risk of fatal vaccine-induced disease from modified live virus vaccines from the labeling"i Further evaluation of supplemental scientific data drove this FDA update; data now peer-reviewed and published Real-world success and experiences from dermatologists and general practice veterinarians around the U.S. and the world further demonstrate Zenrelia's...Read more
TREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn's disease TREMFYA® achieved significant rates of clinical remission and endoscopic improvement versus placebo at Week 12 with a subcutaneous induction regimen, consistent with IV induction Johnson & Johnson is initiating a head-to-head study seeking to demonstrate the superiority of...Read more
The Implantable Tibial Neuromodulation (ITNM) device will expand treatment options for the 16 million people living with urinary urges and involuntary leaks GALWAY, Ireland, Sept. 19, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the Altaviva™ device. The minimally invasive implantable tibial...Read more
KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute RAHWAY, N.J. / Sep 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for...Read more
Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis (AD) Phase 3 data supporting the approval show that treatment with Opzelura resulted in significant efficacy, with no new safety concerns identified This milestone marks the third U.S. approval for Opzelura, which is now indicated to treat mild to moderate AD in non-immunocompromised patients 2+ years of age and nonsegmental vitiligo in...Read more
Revised label allows treatment of DEB patients from birth VYJUVEK can now be applied by patients and caregivers PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK® (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic...Read more
Expands Amneal’s Affordable Medicines portfolio and broadens patient access BRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem®. Amneal had previously been distributing an...Read more
Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand Disease (VWD) and On-Demand and Perioperative Management of Bleeding in Pediatric Patients with VWD1 VONVENDI is the Only Recombinant Von Willebrand Factor Replacement Therapy with Approved Indications in Adults and Children with VWD1 VWD, the Most Common Bleeding Disorder, Impacts More...Read more
Another addition to Amneal’s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50...Read more
SHANGHAI & JERSEY CITY, N.J. / Sep 02, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2 “The FDA...Read more
LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months LEQEMBI IQLIK will be launched on October 6, 2025, in the U.S. TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq:...Read more
Generic Saxenda® is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the U.S. market. This approval and launch add to Teva’s continued commitment to its complex generic medicine portfolio as part of its Pivot to Growth Strategy. Liraglutide injection is indicated for adults with obesity or overweight (excess weight) who also have weight related medical problems, and...Read more
Nuvaxovid™ is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season GAITHERSBURG, Md., Aug. 27, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration has approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in adults 65 years and older or individuals 12 years through 64 years of age with at least...Read more
The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains1 Shipping of the LP.8.1-adapted vaccine will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country NEW YORK & MAINZ, Germany / Aug 27, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE, “Pfizer”)...Read more
CAMBRIDGE, MA / ACCESS Newswire / August 27, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with...Read more
DAWNZERA demonstrated significant and sustained HAE attack rate reduction and long-term disease control Offers longest dosing option for HAE, with dosing every 4 or 8 weeks Compelling profile supported by recently published switch data Ionis’ second independent launch in just nine months, with potential for two additional launches next year Ionis to host webcast today at 12:15pm ET CARLSBAD, Calif. / Aug 21, 2025 / Business Wire /...Read more
SANTA CLARA, Calif. / Aug 20, 2025 / Business Wire / Agilent Technologies Inc. (NYSE: A) today announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for colorectal cancer. This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo® (nivolumab) alone or Opdivo (nivolumab) in...Read more
Wegovy® (semaglutide) injection 2.4 mg is now indicated to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity1 The accelerated approval is based on Part 1 of the ESSENCE trial, in which Wegovy® demonstrated a statistically significant improvement...Read more
Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated Commercial availability of Tonmya is expected in the fourth quarter Company to host webcast...Read more
PAPZIMEOS approval marks a historic milestone for the RRP patient community as the first and only FDA-approved therapy for the treatment of adults with RRP PAPZIMEOS received full approval from the FDA for the treatment of adults with RRP; a confirmatory clinical trial is no longer required RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic HPV 6 or HPV 11 infection, which results in...Read more
Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage BRINSUPRI 10 mg and 25 mg Doses Approved for the Treatment of NCFB BRINSUPRI, a First-in-Class DPP1 Inhibitor Targeting Neutrophilic Inflammation, Is Available by Prescription Through a Comprehensive Specialty Pharmacy Network Insmed to Host Investor Conference Call...Read more
Approval is Another Milestone of Viatris' Ability to Successfully Develop Complex Generic Medicines Approval Granted with Competitive Generic Therapy Eligibility for 100mg/5mL and 200mg/10mL Strengths; Provides Eligibility for 180 Days of Exclusivity PITTSBURGH, Aug. 11, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced the U.S. Food and Drug Administration (FDA) has approved Iron...Read more
TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved the Company’s ketamine product, herein referred to as KETARx™, on August 8th, 2025, for its indicated uses in surgical pain...Read more
According to the FDA, Amphastar's iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer® for the treatment of iron deficiency anemia in patients with chronic kidney disease RANCHO CUCAMONGA, CA / ACCESS Newswire / August 11, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary...Read more
U.S. Commercialization Officially Launched Mont-Saint-Guibert, Belgium – August 8, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of...Read more
Modeyso is the first treatment option for this ultra-rare and aggressive brain tumor, which primarily affects children and young adults Accelerated approval based on an overall response rate in patients with progressive disease following prior therapy Company to host investor webcast on August 27, 2025 For U.S. media and investors only DUBLIN, Aug. 5, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today...Read more
FDA approves single-dose AJOVY® (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents aged 6-17 who weigh 45 kilograms or more, offering a long-awaited monthly treatment option with in-office or at-home administration1 AJOVY expands access across age groups as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for pediatric episodic migraine prevention and...Read more
Leqvio can now be used alone, without addition of statin therapy, as adjunct to diet and exercise for LDL-C reduction in patients with hypercholesterolemia (high LDL-C)1 4 out of 5 atherosclerotic cardiovascular disease (ASCVD) patients do not reach guideline-recommended LDL-C target, reinforcing urgent need for more aggressive LDL-C lowering2-5 Twice-yearly Leqvio is uniquely positioned to help support patient adherence and long-term...Read more
VIZZ is the first and only aceclidine-based eye drop approved to improve near vision in adults with presbyopia, a condition impacting approximately 128 million adults in the United States First once daily solution to treat blurry near vision with proven efficacy for up to 10 hours VIZZ samples and product availability in the United States expected as early as October 2025 Conference call and webcast to be held August 1, 2025 at 8:00...Read more
Proven efficacy across all three key markers of disease—68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits Broad label includes adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence Well-established safety profile, consistent across >2,200 patient years in approved indications C3G and primary IC-MPGN are rare kidney diseases...Read more
Broad labeling inclusive of all disease subtypes for individuals 1 month of age and older PTC will host a conference call on Monday, July 28th at 5:00 pm ET WARREN, N.J., July 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has approved SEPHIENCE™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The...Read more
First of many planned label expansions supporting Vision 2030 goal to become the leading endocrinology rare disease company On track to initiate basket trial for ISS, SHOX deficiency, Turner syndrome, and SGA*, as well as combination therapy trials in achondroplasia and hypochondroplasia, in Q4 2025 COPENHAGEN, Denmark, July 28, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug...Read more
Prefilled syringe presentation offers a convenient administration option to healthcare professionals An estimated one million people develop shingles in the US each year1 PHILADELPHIA / Jul 17, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles...Read more
12-Month Parasiticide Treatment for Dogs Offers Unrivaled Duration of Flea and Tick Protection Compared to Existing Products RAHWAY, N.J. / Jul 10, 2025 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration (FDA) approval of BRAVECTO® QUANTUM (fluralaner for...Read more
The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding to the established safety profile of the treatment INDIANAPOLIS, July 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Lilly's...Read more
The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation MARLBOROUGH, Mass., July 7, 2025 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The updated labeling now includes approval for...Read more
First new on-demand HAE treatment in over a decade, with potential to transform management of the disease Data demonstrated rapid symptom relief and attack resolution regardless of attack severity, location, age, or use of long-term prophylaxis, and well-established safety profile Management to host conference call today at 8:30 a.m. ET CAMBRIDGE, Mass. & SALISBURY, England / Jul 07, 2025 / Business Wire / KalVista...Read more
GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 µg/mL IgA in a 10% Solution is Approved for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency1 U.S. Commercialization of GAMMAGARD LIQUID ERC Projected to Begin in 2026 Company Announces Future Manufacturing Discontinuation End Date for Takeda's First-Generation Low-IgA Product, A Freeze-Dried Formulation in...Read more
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access Only about 2 in 10 eligible patients currently receive cell therapy treatment; today’s announcement will reduce unnecessary barriers for patients and providers PRINCETON, N.J. / Jun 26, 2025 / Business Wire /...Read more
MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States. The PMA approval is backed by best-in-class evidence from the Company’s C-GUARDIANS pivotal...Read more
With this approval, pediatric patients aged five years and older with active lupus nephritis will have a first-of-its-kind treatment option for at-home administration. PHILADELPHIA / Jun 24, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody,...Read more
Based on TROPION-Lung05 results and supported by data from TROPION-Lung01 First and only TROP2-directed therapy approved in the US for the treatment of lung cancer WILMINGTON, Del. / Jun 24, 2025 / Business Wire / DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior...Read more
Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, debilitating and relapsing rare skin disease affecting approximately 27,000 adults in the U.S. whose disease is uncontrolled by systemic corticosteroids Dupixent is now approved in the U.S. to treat eight distinct diseases with underlying type 2...Read more
Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma (FL) Patients with relapsed or refractory FL achieved significantly improved progression-free survival with Monjuvi in combination with rituximab and lenalidomide in the Phase 3 registration trial This milestone represents the second approved...Read more
Approval Based on Phase 3 PURPOSE 1 and PURPOSE 2 Data that Showed ≥99.9% of Participants Remained HIV Negative on Twice-Yearly Injectable Yeztugo Yeztugo, Nearly 20 Years in the Making, Represents a Major Breakthrough in the Fight Against HIV FOSTER CITY, Calif. / Jun 18, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the...Read more
FDA priority review and approval based on interim results sets a positive precedent, paving the path for future Multikine approval Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating...Read more
Approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1) RAHWAY, N.J. / Jun 13, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1...Read more
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS Newswire / June 12, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of...Read more
ZUSDURI (formerly known as UGN-102) is a localized medication designed for potent tumor ablation delivered by innovative RTGel® technology. Approval supported by pivotal Phase 3 ENVISION trial demonstrating 78% of patients achieved complete response (CR) at 3 months, and 79% of those responders maintained complete response at 12 months after the 3-month visit (DOR). Manageable safety profile characterized primarily by mild to moderate...Read more
Key complex product approval in the Affordable Medicines segment this year Commercial launch planned for third quarter of 2025 BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte®. Pred Forte and its design are trademarks...Read more
Approval follows Priority Review and is supported by the robust TRUST clinical program, in which IBTROZI treatment demonstrated high, durable response rates and brain-penetrant efficacy across different lines of therapy The safety and tolerability of IBTROZI have been well established in the pivotal program, with one of the largest safety datasets in ROS1+ NSCLC showing a favorable and consistent profile Company to host conference call...Read more
MAVYRET® (glecaprevir/pibrentasvir) is the first and only oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV)* With this approval, providers can now treat HCV patients immediately at the time of diagnosis HCV is a curable condition, but patients can often go undiagnosed.1 If left untreated, people with acute HCV could progress to chronic disease, including liver-related...Read more
ENFLONSIA is a preventive monoclonal antibody designed to protect infants against a spectrum of RSV disease severity, including worsening disease requiring hospitalization ENFLONSIA is the first and only RSV preventive option administered to infants using the same dose regardless of weight RAHWAY, N.J. / Jun 09, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S....Read more
FLORHAM PARK, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today announced that the U.S. Food and Drug Administration (FDA) has approved Phathom’s Citizen Petition filed on December 11, 2024 and communicated the Agency’s intention to correct the Orange Book to recognize the proper 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets, extending through May 3, 2032. About...Read more
Nubeqa is the first and only in the U.S. and FDA-approved androgen receptor inhibitor (ARi) for the treatment of patients with hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT), with or without chemotherapy This third approval is based on positive results from the pivotal Phase III ARANOTE trial and broadens the indication profile of darolutamide in mHSPC, enabling its use in combination...Read more
mNEXSPIKE becomes Moderna's third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control...Read more
KHINDIVI is the first and only FDA-approved hydrocortisone oral solution Commercial launch expected the week of June 2nd Eton expects combined peak sales of KHINDIVI and ALKINDI SPRINKLE® (hydrocortisone) oral granules to exceed $50 million DEER PARK, Ill., May 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and...Read more
In pivotal Phase 3 trials, TRYPTYR demonstrated rapid natural tear production as early as Day 11-2 TRYPTYR is a first-in-class TRPM8 receptor agonist that rapidly stimulates natural tear production in patients with Dry Eye Disease (DED)3 Approximately 38 million individuals in the U.S. are living with DED, yet less than 10% of diagnosed patients are being treated with a prescription product4 GENEVA / May 28, 2025 / Business Wire /...Read more
The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, known as severe mitral annular calcification (MAC) Tendyne offers a new treatment option for patients who are not candidates for open-heart surgery or mitral repair This approval expands Abbott's portfolio of minimally invasive structural heart therapies in the U.S. ABBOTT PARK, Ill., May 27, 2025...Read more
FDA’s approval of YUTREPIA paves the way for prescribers to add a new treatment option for patients with PAH and PH-ILD YUTREPIA is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort Demonstrated tolerability and titratability in the pivotal INSPIRE study Liquidia will host a webcast Tuesday, May 27, 2025 at 8:30 a.m. ET to provide an update on commercial launch...Read more
Nucala is the only approved biologic studied in a wide COPD population with an eosinophilic phenotype characterized by blood eosinophil count (BEC) starting at 150 cells/μL Approval based on the positive MATINEE and METREX phase III trials MATINEE data included reduction of exacerbations leading to hospitalization and/or emergency department visits Nearly 70% of patients in the US who are inadequately controlled on inhaled triple...Read more
Once-daily ZORYVE foam provides powerful clearance and rapid itch relief from head to toe with no limitation on duration of use More than half of the nearly 9 million people in the United States with plaque psoriasis experience scalp involvement Healthcare providers and individuals with plaque psoriasis can now choose ZORYVE foam or cream to treat plaque psoriasis anywhere it appears on the body Fifth FDA approval for ZORYVE in less...Read more
Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine months Susvimo’s innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the US Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating wet,...Read more
Stryker's first basivertebral nerve ablation system targets the basivertebral nerve to provide relief from chronic* vertebrogenic low back pain. PORTAGE, Mich., May 19, 2025 /PRNewswire/ -- Stryker (NYSE:SYK), a global leader in medical technologies, announced that its OptaBlate basivertebral nerve ablation system (OptaBlate BVN) received 510(k) clearance from the U.S. Food and Drug Administration. OptaBlate BVNA is used in a...Read more
Zynyz® (retifanlimab-dlwr), a PD-1 inhibitor, is now approved for the treatment of advanced squamous cell carcinoma of the anal canal (SCAC) in combination with chemotherapy and as a monotherapy Patients with SCAC treated with Zynyz achieved a statistically significant improvement in progression-free survival and improvement in overall survival WILMINGTON, Del. / May 15, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that...Read more
Brekiya® becomes the first and only DHE autoinjector that allows patients to self-administer the same medication used in hospitals in a ready-to-use form Product will be available for appropriate patients in the second half of 2025 BRIDGEWATER, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has...Read more
NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil® (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. This...Read more
EMRELIS is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options Lung cancer remains the leading cause of cancer-related deaths throughout the world1 NORTH CHICAGO, Ill., May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that EMRELIS™ (telisotuzumab vedotin-tllv) has been granted...Read more
WELIREG becomes the only approved and available treatment in the U.S. for eligible patients with advanced PPGL RAHWAY, N.J. / May 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric...Read more
AVMAPKI plus FAKZYNJA to be commercially available by prescription as a convenient oral combination co-packaged together and will be known as “AVMAPKI FAKZYNJA CO-PACK” Accelerated approval, well ahead of the June 30, 2025 PDUFA action date, was based on the Phase 2 RAMP 201 study that demonstrated a 44% overall response rate in patients with KRAS mutant recurrent LGSOC Verastem to host investor conference call and webcast today at 2:30...Read more
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025 SELARSDI is approved for all indications matching the reference product SELARSDI is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and...Read more
Transforming Care for Severe AS Patients IRVINE, Calif. / May 01, 2025 / Business Wire / Edwards Lifesciences (NYSE: EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients. Approval of the SAPIEN 3...Read more
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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