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ViiV Submits Fostemsavir NDA to the FDA for Treatment of HIV in Adults with Few Treatment Options Available

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of …

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ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, a privately held immunotherapy company, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its interleukin-15 (IL-15) agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ (CIS). This grant …

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FDA Grants Breakthrough Therapy Designation to Bristol-Myers Squibb’s Orencia to Help Prevent Acute Graft-Versus-Host Disease

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of …

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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 …

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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. …

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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 …

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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) …

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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 …

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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 …

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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 …

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