Home / FDA News

FDA News

FDA Grants Priority Review to Merck’s sBLA for Keytruda Plus Inlyta as First-Line Treatment for Advanced Renal Cell 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 accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase …

Read More »

FDA Announces Breakthrough Therapy Designation to CymaBay’s Seladelpar for Treatment of Primary Biliary Cholangitis

NEWARK, Calif., Feb. 15, 2019 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for seladelpar for the treatment of early stage primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adult patients with …

Read More »

Sarepta Announces FDA Acceptance of Golodirsen NDA for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53

CAMBRIDGE, Mass., Feb. 14, 2019 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced the Food and Drug Administration, Division of Neurology (the Division), has accepted its New Drug Application (NDA) seeking accelerated approval for golodirsen (SRP-4053) and provided a regulatory action …

Read More »

FDA Approves Novartis’ Egaten for the Treatment of Fascioliasis, a Neglected Tropical Disease

Basel, Switzerland, February 13, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Egaten® (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader access …

Read More »

FDA Grants Priority Review for Bavencio Plus Inlyta for the Treatment of Advanced Renal Cell Carcinoma

Rockland, MA and New York, NY, February 11, 2019 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application …

Read More »

FDA Approves Janssen and Genmab’s Split-Dosing Regimen for Darzalex

Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved a split dosing regimen for DARZALEX® (daratumumab).  The approval will be included in an update to the Prescribing Information in order to provide healthcare professionals the option to split the first infusion of DARZALEX …

Read More »

FDA Grants Priority Review to Merck’s sBLA for Keytruda for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell 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 accepted a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the …

Read More »

Apellis’ APL-2 Receives Fast Track Designation from the FDA for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

WALTHAM Mass., and CRESTWOOD, Ky., Feb. 11, 2019 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals Inc., (Nasdaq:APLS) a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation …

Read More »

FDA Grants Clementia’s Palovarotene Rare Pediatric Disease Designation for Fibrodysplasia Ossificans Progressiva

MONTREAL, Feb. 11, 2019 (GLOBE NEWSWIRE) — Clementia Pharmaceuticals Inc. (Nasdaq: CMTA), a clinical-stage biopharmaceutical company innovating treatments for people with ultra-rare bone disorders and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to palovarotene for the treatment of fibrodysplasia …

Read More »

FDA Approves Grifols’ Procleix Babesia Assay for Donor Screening on Procleix Panther System

BARCELONA, Spain, Feb. 7, 2019 /PRNewswire/ — Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, announced today that the U.S. Food and Drug Administration (FDA) approved the Procleix Babesia assay, a qualitative assay for the detection of the ribosomal RNA …

Read More »