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FDA Approves mRESVIA (respiratory syncytial virus vaccine) for Prevention of Lower Respiratory Tract Disease Caused by RSV

CAMBRIDGE, MA / ACCESSWIRE / May 31, 2024 -- Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytia

FDA Approves Onyda XR, a Once-Daily, Non-Stimulant, Liquid Treatment for ADHD

May 29, 2024 - Business Wire -- Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological diso

FDA Approves Bkemv (eculizumab-aeeb), an Interchangeable Biosimilar to Soliris

May 28, 2024 -- Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is a

FDA Approves Yesafili (aflibercept-jbvf), an Interchangeable Biosimilar to Eylea

May 20, 2024 -- The U.S. Food and Drug Administration (FDA) has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products work by inhibiting vasc

FDA Approves Opuviz (aflibercept-yszy), an Interchangeable Biosimilar to Eylea

May 20, 2024 -- The U.S. Food and Drug Administration (FDA) has approved Opuviz (aflibercept-yszy), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products work by inhibiting vascul

FDA Grants Accelerated Approval for Imdelltra (tarlatamab-dlle) for the Treatment of Extensive-Stage Small Cell Lung Cancer

THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Imdelltra™ (tarlatamab-dlle) for the treatment of

FDA Approves Myhibbin (mycophenolate mofetil) Oral Suspension for Prophylaxis of Organ Rejection

WOBURN, Mass. May 6, 2024 -- Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, annou

FDA Approves Beqvez (fidanacogene elaparvovec-dzkt) One-Time Gene Therapy for Adults with Hemophilia B

NEW YORK--(BUSINESS WIRE) April 26, 2024 -- Pfizer Inc. (NYSE: PFE)announced today that the U.S. Food and Drug Administration (FDA) has approved Beqvez™ (fidanacogene elaparvovec-dzkt) for the treatme

FDA Approves Xolremdi (mavorixafor) for Use in Patients with WHIM Syndrome

BOSTON, April 29, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Foo

FDA Approves Libervant (diazepam) Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years

WARREN, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvemen

FDA Approves Hercessi (trastuzumab-strf), a Biosimilar to Herceptin

DURHAM, N.C., April 29, 2024 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care t

FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections

April 24, 2024 -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by su