FDA News

FDA Approves Genentech’s Tecentriq Plus Chemotherapy for Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer …

Read More »

FDA Grants Regenerative Advanced Therapy Designation to Adaptimmune’s Investigational Synovial Sarcoma Treatment

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Dec. 03, 2019 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for ADP-A2M4 for the treatment of synovial sarcoma. …

Read More »

Immunomedics Resubmits its BLA to the FDA for Accelerated Approval of Sacituzumab Govitecan for Treatment of Metastatic Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for …

Read More »

FDA Advisory Committee Scheduled to Review Reblozyl for Use in Patients with Myelodysplastic Syndromes

PRINCETON, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will hold a review of Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for the use of Reblozyl® (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) …

Read More »

FDA Rejects Lexicon’s NDA for Sotagliflozin for Treatment of Patients with Type 1 Diabetes

The Woodlands, Texas, December 2, 2019 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the Office of New Drugs of the U.S. Food and Drug Administration (FDA) has reiterated the FDA’s prior position and denied Lexicon’s appeal of the Complete Response Letter in relation to the New Drug Application for …

Read More »

FDA Grants Priority Review to Merck’s sBLA for Keytruda in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer

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. The application seeks approval of KEYTRUDA monotherapy …

Read More »

FDA Approves Oxbryta, the First Drug Specifically Targeting the Root Cause of Sickle Cell Disease

SOUTH SAN FRANCISCO, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) —  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Oxbryta™ (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older.1 Oxbryta, an oral therapy …

Read More »

FDA Approves Alnylam’s Givlaari for Treatment of Adults with Acute Hepatic Porphyria

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved GIVLAARI™ (givosiran) injection for subcutaneous use for the treatment of adults with acute hepatic porphyria (AHP). AHP is a family of ultra-rare, genetic diseases characterized by debilitating, potentially life-threatening …

Read More »

FDA Grants Newron’s Sarizotan Rare Pediatric Disease Designation for Treatment of Rett Syndrome

MILAN & MORRISTOWN, N.J.–(BUSINESS WIRE)–Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announced today that the U.S. Food and Drug Administration (FDA) has granted the Rare Pediatric Disease designation for …

Read More »

FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing AVASTIN®i (bevacizumab). The BLA for SB8 was submitted by Samsung Bioepis in September 2019. If …

Read More »