Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Wednesday, August 13, 2025

FDA Approves Arynta (lisdexamfetamine) Oral Solution for ADHD and Binge Eating Disorder

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In continuation of my update on  lisdexamfetamine Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals' Arynta™ (lisd...
Tuesday, August 12, 2025

FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria

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In continuation of my update on  nitisinone Cycle Pharmaceuticals has announced   the FDA approval of  Harliku (nitisinone) Tablets for the ...
Monday, August 11, 2025

FDA Grants Accelerated Approval to Zegfrovy (sunvozertinib) for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseas...
Friday, July 25, 2025

FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive Non-Small Cell Lung Cancer

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Nuvation Bio Inc. announced the U.S. Food and Drug Administration (FDA)  approval of  Ibtrozi (taletrectinib) for the treatment of adult pat...
Monday, June 16, 2025

FDA Grants Accelerated Approval for Vanrafia (atrasentan) for Proteinuria Reduction in Primary IgA Nephropathy

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Novartis  announced the US Food and Drug Administration (FDA)  accelerated approval for Vanrafia ®  (atrasentan), a potent and selective end...
Saturday, June 14, 2025

FDA Approves Mezofy (aripiprazole) Oral Film for the Treatment of Schizophrenia

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In continuation of my update on Aripiprazole CMG Pharmaceuticals, an affiliate of Cha Biotech, announced on the 16th that it had received pr...
Thursday, June 12, 2025

FDA Approves Atzumi (dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine

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Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395),  announced  the U.S. Food and Drug Administration (FDA) approval of    New Drug Applic...
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...