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FDA Approves Ozempic to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes and Known Heart Disease

PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic® (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 …

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FDA Grants Fast Track Designation to Arena’s APD418 for Patients with Decompensated Heart Failure

SAN DIEGO, Jan. 16, 2020 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, in development for the treatment of decompensated heart failure (DHF). “With approximately 10 million …

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ArcherDX Personalized Cancer Monitoring Technology Designated by FDA as Breakthrough Device

BOULDER, Colo., Jan. 14, 2020 /PRNewswire/ — ArcherDX, Inc., today announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Personalized Cancer Monitoring (PCM) technology, a bespoke, minimally-invasive and highly-sensitive product intended for early-stage cancer treatment monitoring and recurrence surveillance. ArcherDX’s technology enables …

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FDA Grants Priority Review to Clovis Oncology’s Rubraca for Treatment of Advanced Prostate Cancer

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Rubraca® (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. Clovis …

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FDA Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo Plus Yervoy in First-Line NSCLC

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. …

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FDA Approves Lannett’s NDA For Branded Anesthetic Product, Cocaine Hydrochloride Nasal Solution

PHILADELPHIA, Jan. 13, 2020 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the company’s branded local anesthetic product.  “The FDA’s approval …

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Ultragenyx and Kyowa Kirin Submit sBLA to the FDA for Crysvita for Tumor-Induced Osteomalacia

NOVATO, Calif. and TOKYO, Jan. 13, 2020 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) today announced that they submitted a supplemental Biologics License Application (sBLA) to the U.S. …

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FDA Grants Fast Track Designation to Imago’s Bomedemstat for Treatment of Essential Thrombocythemia

SAN FRANCISCO–(BUSINESS WIRE)–Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of bomedemstat (IMG-7289) for the treatment of essential thrombocythemia (ET), a bone marrow disease associated with high …

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FDA Accepts and Grants Priority Review to sNDA for Lynparza as First-Line Maintenance with Bevacizumab in Advanced Ovarian Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with bevacizumab has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the maintenance treatment …

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FDA Grants Orphan Drug Designation to Dova’s Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia

DURHAM, N.C., Jan. 13, 2020 /PRNewswire/ — Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™), has been granted Orphan Drug Designation1 (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treatment of chemotherapy-induced thrombocytopenia (CIT). Enrollment remains ongoing for …

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