FDA News

Alnylam Initiates Rolling Submission of NDA to FDA for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company has initiated a rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria …

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FDA Grants Fast Track Designation to Meissa Vaccines’ MV-012-968 Vaccine for Respiratory Syncytial Virus

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent viral respiratory infections, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MV-012-968, an investigational, live attenuated vaccine for protection against respiratory syncytial virus (RSV) infection. The FDA’s Fast Track …

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FDA Approves Blueprint Medicines’ Ayvakit for Treatment of Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

CAMBRIDGE, Mass., Jan. 9, 2020 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth …

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FDA Approves Keytruda for Certain Patients with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in …

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FDA Approves sNDA for Astellas’ Mycamine for the Treatment of Invasive Candidiasis in Pediatric Patients Younger than 4 Months

NORTHBROOK, Ill., Jan. 8, 2020 /PRNewswire/ — Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for MYCAMINE® (micafungin for injection) in support of the treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in …

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Blueprint Medicines Announces Top-line Data for Pralsetinib and Initiates Rolling NDA Submission to FDA for Treatment of RET Fusion-Positive NSCLC

CAMBRIDGE, Mass., Jan. 8, 2020 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced independent centrally reviewed top-line data for pralsetinib in patients with RET fusion-positive non-small cell lung cancer (NSCLC). The data from the ongoing …

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FDA Grants Rare Pediatric Disease Designation for Aruvant’s ARU-1801 for the Treatment of Sickle Cell Disease

NEW YORK and BASEL, Switzerland, Jan. 8, 2020 /PRNewswire/ — Aruvant, a clinical-stage biopharmaceutical company focused on developing and commercializing transformative therapies for the treatment of severe blood disorders, today announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease designation to ARU-1801, Aruvant’s investigational therapy for …

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FDA Approves Lynparza as First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not …

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FDA Approves Flexion Therapeutics’ sNDA to Revise Zilretta Product Label for Treatment of Osteoarthritis Knee Pain

BURLINGTON, Mass., Dec. 26, 2019 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the product label for ZILRETTA (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain. Key …

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FDA Accepts Immunomedics’ BLA Resubmission for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., Dec. 26, 2019 (GLOBE NEWSWIRE) — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan …

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