FDA News

FDA Expands Approval of Leo Pharma’s Enstilar Foam and Taclonex Topical Suspension in Treatment of Plaque Psoriasis

MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma Inc., a wholly owned subsidiary of LEO Pharma A/S, announced today the U.S. Food and Drug Administration (FDA) has expanded the approved indication for Enstilar® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The FDA …

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FDA Approves Merck’s Keytruda as Monotherapy for Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

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 recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose …

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FDA Approves Bayer’s Nubeqa for Treatment of Patients with Non-Metastatic Castration-Resistant Prostate Cancer

WHIPPANY, N.J., July 30, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1 The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation …

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Momenta’s M281 Granted Fast Track Designation from the FDA for Treatment of Hemolytic Disease of the Fetus and Newborn

CAMBRIDGE, Mass., July 30, 2019 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for M281, Momenta’s IgG1 monoclonal antibody targeting FcRn, …

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FDA Grants Regenerative Medicine Advanced Therapy Designation to Orchard’s Investigational Wiskott-Aldrich Syndrome Treatment

BOSTON and LONDON, July 29, 2019 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for OTL-103, Orchard’s ex …

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GENFIT’s Elafibranor Receives Orphan Drug Designation for the Treatment of Primary Biliary Cholangitis

Lille (France), Cambridge (Massachusetts, United States), July 29, 2019 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines …

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FDA Advisory Committee Recommends Approval of Boehringer Ingelheim’s Ofev for the Treatment of Systemic Sclerosis Associated with ILD

RIDGEFIELD, Conn., July 25, 2019 /PRNewswire/ — Boehringer Ingelheim today announced that the FDA’s Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev® (nintedanib) for the treatment of systemic sclerosis associated interstitial lung disease, or SSc-ILD. “The committee’s recommendation brings nintedanib one step closer to becoming available to patients who …

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FDA Accepts and Grants Priority Review to Epizyme’s NDA for Tazemetostat for the Treatment of Epithelioid Sarcoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent. Epizyme has proposed an indication of metastatic …

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FDA Approves Lilly’s Baqsimi, the First Treatment for Severe Hyperglycemia That Can Be Administered Without An Injection

INDIANAPOLIS, July 24, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved BAQSIMI™ (glucagon) nasal powder 3 mg for the treatment of severe hypoglycemia in people with diabetes ages four years and above, Eli Lilly and Company (NYSE: LLY) announced today. BAQSIMI is the first and only nasally administered glucagon, and it …

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Aeglea BioTherapeutics Receives FDA Breakthrough Therapy Designation for Pegzilarginase for Treatment of Arginase 1 Deficiency

AUSTIN, Texas, July 24, 2019 (GLOBE NEWSWIRE) — Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to the Company’s …

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