FDA News

FDA Panel Recommends Approval of Pfizer’s Epoetin Alfa Biosimilar Across All Indications

Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company’s proposed epoetin alfa biosimilar across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a U.S. FDA …

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Regeneron and Sanofi Announce FDA Approval of Kevzara for Treatment of Rheumatoid Arthritis

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), …

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FDA Grants Accelerated Approval to Merck’s Keytruda for Solid Tumors with Specific Biomarkers

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 a new indication for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy. KEYTRUDA is now indicated for the treatment of adult and pediatric patients with unresectable or metastatic, …

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FDA Approves Genentech’s Actemra for Treatment of Giant Cell Arteritis

South San Francisco, CA — May 22, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition. Actemra is the …

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GlycoMimetics’ Investigational Acute Myeloid Leukemia Drug Receives Breakthrough Therapy Designation from the FDA

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) to the company’s drug candidate GMI-1271, an E-selectin antagonist currently being evaluated in the Phase 2 portion of a Phase …

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FDA Approves Merck’s Keytruda for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma

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 two new indications for KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In …

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FDA Expands Approval of Vertex’s Kalydeco to Treat Additional Mutations of Cystic Fibrosis

BOSTON–(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO® (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. …

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Sangamo’s Hemophilia A Gene Therapy Candidate Receives Fast Track Status from the FDA

RICHMOND, Calif., May 16, 2017 /PRNewswire/ — Sangamo Therapeutics, Inc. (NASDAQ: SGMO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SB-525, the Company’s clinical stage cDNA gene therapy candidate for hemophilia A, which is being developed as part of an exclusive, global …

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FDA Grants Priority Review to Bayer’s Investigational Follicular Lymphoma Drug Copanlisib

WHIPPANY, N.J., May 17, 2017 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. …

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Imara’s Sickle Cell Disease Candidate Receives Rare Pediatric Disease Designation from the FDA

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Imara Inc., a biotechnology company dedicated to developing novel therapeutics for patients with sickle cell disease (SCD) and other hemoglobinopathies, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to IMR-687, the company’s lead product candidate. IMR-687 is the first SCD …

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