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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

BRTV reports on Beijing Memorial Pharmaceutical Research and Development Co.,Ltd.

At 20:00 on May 15, 2024, Beijing TV Finance and Economy Channel (BRTV) made a publicity report on Beijing Memorial Pharmaceutical Research and Development Co.,Ltd. (BMPRD) and the programme was broad

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