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
First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies gMG patients taking IMAAVY demonstrated 20 months of lasting disease...Read more
RINVOQ (upadacitinib) is now the first and only oral Janus Kinase (JAK) inhibitor approved for the treatment of GCA in adults Also known as temporal arteritis, GCA is the most common vasculitis affecting adults in Western countries2 This marks the ninth approved indication for RINVOQ in the U.S., across rheumatology, gastroenterology, and dermatology1 NORTH CHICAGO, Ill., April 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today...Read more
ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile ZEVASKYN to be available through Qualified Treatment Centers beginning in 3Q 2025 Abeona Assist™ patient services program...Read more
Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success GALWAY, Ireland and SAN DIEGO, April 25, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT),...Read more
Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatment CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) --...Read more
LIVMARLI Tablet formulation approved for patients with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) FOSTER CITY, Calif. / Apr 14, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of LIVMARLI® (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome...Read more
Based on the Phase 3 CheckMate-9DW trial, Opdivo plus Yervoy demonstrated a statistically significant overall survival benefit compared to investigator’s choice of lenvatinib or sorafenib1 In the trial, 38% of patients were still alive at 3 years with this dual immunotherapy vs. 24% with the comparator arm1 PRINCETON, N.J. / Apr 11, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug...Read more
VYVGART, the first-in-class FcRn blocker, now offers three administration options, including self-injection with a prefilled syringe Self-injection provides gMG and CIDP patients with flexibility for when and where to receive treatment – at home, while ‘on the go’ or in a healthcare setting Approval reflects commitment to innovating the patient experience with individualized, safe and effective therapies Amsterdam, the Netherlands...Read more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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