Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Saturday, September 21, 2024

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

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Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated ur...
Wednesday, September 11, 2024

FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

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Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohe...
Wednesday, September 4, 2024

FDA Approves Fruzaqla (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

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Takeda announced the U.S. Food and Drug Administration (FDA) has approval of  Fruzaqla™ (fruquintinib), an oral targeted therapy for adults ...
Wednesday, August 28, 2024

FDA Approves Aurlumyn (iloprost) as the First Medication to Treat Severe Frostbite

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The U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finge...
Saturday, August 24, 2024

FDA approves tepotinib for metastatic non-small cell lung cancer | FDA

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FDA approves tepotinib for metastatic non-small cell lung cancer On February 15, 2024, the Food and Drug Administration granted traditional ...
Wednesday, August 21, 2024

Ipsen’s Onivyde Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Adenocarcinoma, Approved by FDA

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Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug ap...
Friday, August 16, 2024

Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration

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Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) a rare disease therapeutics company, today announced it resubmitted its New Drug Application (NDA)...
Thursday, August 15, 2024

Zealand Pharma Submits New Drug Application to the US FDA for Glepaglutide in Short Bowel Syndrome

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Zealand Pharma A/S  announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for glepaglutide, ...
Tuesday, August 13, 2024

FDA Grants Soligenix Fast Track Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

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Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing ...
Thursday, August 8, 2024

Defender Pharmaceuticals Receives Complete Response Letter from the U.S. Food and Drug Administration for its Intranasal Scopolamine (DPI-386) New Drug Application for the Prevention of Nausea and Vomiting Induced by Motion in Adults

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Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced the...
Saturday, February 24, 2024

FDA Approves Miebo (perfluorohexyloctane) Ophthalmic Solution for the Treatment of the Signs and Symptoms of Dry Eye Disease

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Bausch + Lomb Corporation, announced that the U.S. Food and Drug Administration (FDA) has approved Miebo ™  (perfluorohexyloctane ophthalmic...
Thursday, February 22, 2024

FDA Approves Lumryz (sodium oxybate) for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy

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In continuation of my update on Lumryz Avadel Pharmaceuticals plc   a biopharmaceutical company announced   the U.S. Food & Drug Adminis...
Tuesday, February 20, 2024

FDA Approves Mydcombi (tropicamide and phenylephrine hydrochloride) Ophthalmic Spray for Inducing Mydriasis

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In continuation of my update on phenylephrine hydrochloride Phenylephrine Tropicamide Eyenovia, Inc, announced  the U.S. Food and Drug Admin...
Thursday, February 15, 2024

FDA Grants Accelerated Approval for Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis Associated with a Mutation in the SOD1 Gene

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Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA)   approval of  Qalsody (tofersen) 100 mg/15mL injection for...
Wednesday, February 14, 2024

FDA Approves Abilify Asimtufii (aripiprazole) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults

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In continuation of my update on aripiprazole Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announced ...
Tuesday, February 13, 2024

FDA Approves Uzedy (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults

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In continuation of my update on  Uzedy (risperidone) Teva Pharmaceuticals,  announced  the U.S. Food and Drug Administration (FDA)  approval...