FDA Approves Capvaxive (pneumococcal 21-valent conjugate vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults
RAHWAY, N.J.--(BUSINESS WIRE) June 17, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved Ca
FDA Approves Vigafyde (vigabatrin) as the First and Only Ready-to-Use Vigabatrin Oral Solution
PARSIPPANY, N.J.--(BUSINESS WIRE) June 17, 2024 --Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced tod
FDA Approves Yimmugo (immune globulin intravenous, human-dira) to Treat Primary Immunodeficiencies
Barcelona, Spain, June 17, 2024 -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that Biotest, a Grifols Group company, h
FDA Grants Accelerated Approval to Iqirvo (elafibranor) for the Treatment of Primary Biliary Cholangitis
PARIS, FRANCE, 10 June 2024 -- Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablet
FDA Approves Rytelo (imetelstat) for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia
FOSTER CITY, Calif.--(BUSINESS WIRE) June 6, 2024 -- Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today
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
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