FDA News

FDA Approves Merck’s Keytruda for Use at an Additional Recommended Dose of 400 mg Every 6 Weeks for All Approved Adult Indications

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 an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy and combination …

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Personal Genome Diagnostics Receives FDA Clearance for PGDx elio Tissue Complete, the First Comprehensive Genomic Profiling Diagnostic Kit for Cancer

BALTIMORE–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in …

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FDA Grants Breakthrough Therapy Designation to Takeda’s Mobocertinib for Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon …

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FDA Approves Koselugo for Treatment of Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved the kinase inhibitor KOSELUGO™ (selumetinib) for the treatment of pediatric patients two years of age and older with …

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FDA Accepts and Grants Priority Review to Fennec Pharmaceuticals’ NDA for Pedmark

Research Triangle Park, N.C., April 13, 2020 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for the company’s New Drug Application (NDA) for PEDMARK™ (a unique formulation …

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FDA Issues Emergency Use Authorization for Blood Purification Device to Treat COVID-19

The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. The authorized product works by reducing the amount …

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FDA Grants Breakthrough Therapy Designation to Bavencio for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Rockland, MA and New York, US, April 9, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration …

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FDA Grants Vapotherm’s Oxygen Assist Module Breakthrough Device Designation

EXETER, N.H.–(BUSINESS WIRE)–Vapotherm, Inc. (NYSE: VAPO) (“Vapotherm” or the “Company”), a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI® Technology products that are used to treat patients of all ages suffering from respiratory distress, today announced that the U.S. Food and Drug Administration (FDA) …

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FDA Approves Pfizer’s Braftovi Plus Cetuximab for Previously Treated Metastatic CRC Patients with a BRAF-V600 Mutation

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.1 The approval is …

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Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sotatercept for the treatment of patients …

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