FDA News

FDA Accepts Tanezumab BLA for Treatment of Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis

Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have …

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FDA Grants Priority Review to MorphoSys’ BLA for Tafasitamab and Lenalidomide for Treatment of Relapsed/Refractory DLBCL

MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) announced today that the U.S. Food and Drug Administration (FDA) accepted filing of MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab, the Company’s investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment …

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Mallinckrodt Initiates Rolling Submission of NDA to the FDA for Terlipressin for Treatment of Patients with Hepatorenal Syndrome Type 1

STAINES-UPON-THAMES, United Kingdom, March 2, 2020 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced it initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for terlipressin, an investigational agent being investigated for the treatment of hepatorenal syndrome type 1 (HRS-1), by submitting its clinical …

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Biohaven’s Nurtec Receives FDA Approval for the Acute Treatment of Migraine in Adults

NEW HAVEN, Conn., Feb. 27, 2020 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced that the U.S. Food and Drug Administration (FDA) has approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine in adults. NURTEC ODT is the first FDA-approved product for Biohaven, a company dedicated …

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FDA Accepts and Grants Priority Review to Crysvita sBLA for Treatment of Tumor-Induced Osteomalacia

NOVATO, Calif. and TOKYO, Feb. 27, 2020 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions using the latest biotechnology, today announced that the U.S. …

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FDA Grants Breakthrough Therapy Status to Debiopharm’s Debio 1143 for Front-Line Treatment of Head and Neck Cancer

LAUSANNE, Switzerland, Feb. 27, 2020 /PRNewswire/ — Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, today announced that the American Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for Debio 1143, the most clinically advanced IAP antagonist, for the treatment of patients with confirmed diagnosis of previously untreated, …

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FDA Delays PDUFA Target Action Date for Zogenix’s Fintepla for Treatment of Dravet Syndrome

EMERYVILLE, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) — Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for FINTEPLA® for the treatment of seizures associated with …

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FDA Grants Tessa’s CAR-T Cell Therapy Regenerative Medicine Advanced Therapy Designation for Treatment of Classical Hodgkin Lymphoma

SINGAPORE, Feb. 27, 2020 /PRNewswire/ — Tessa Therapeutics (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments, today announced that the Company’s investigational CD30-directed autologous chimeric antigen receptor T cell (CD30 CAR-T) therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration …

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Acacia Pharma Announces FDA Approval of Barhemsys for Treatment and Prevention of Postoperative Nausea and Vomiting

Cambridge, UK and Indianapolis, US – 27 February 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer …

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FDA Advisory Committee Votes in Favor of Lilly’s Cyramza as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

INDIANAPOLIS, Feb. 26, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 6-5 that CYRAMZA® (ramucirumab) plus erlotinib demonstrated a favorable benefit/risk profile for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC), based on the results of the positive …

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