FDA Approves PiaSky (crovalimab-akkz) for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

June 24, 2024 -- The U.S. Food and Drug Administration (FDA) has approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemogl

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FDA Approves Sofdra (sofpironium) Topical Gel for the Treatment of Primary Axillary Hyperhidrosis

Philadelphia and Phoenix US, 20 June 2024 -- Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased to announce the US Food and Drug Administration (F

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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