SOUTH SAN FRANCISCO, Calif. — Genentech, Inc. a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with...
Latest News
GUILDFORD, England, May 15, 2023 (GLOBE NEWSWIRE) — SiSaf Ltd, an RNA delivery and therapeutics company, announces that SIS-101-ADO, its siRNA therapeutic for patients with Autosomal Dominant Osteopetrosis Type 2 (ADO2), has been granted Orphan Drug Designation by the U.S. FDA. In addition, due to the serious manifestations of this...
PRINCETON, N.J. — Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation...
PRINCETON, NJ – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration...
THOUSAND OAKS, Calif. – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The FDA grants Priority...
CLEVELAND, Ohio — Abeona Therapeutics Inc. announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company’s Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB)....
Washington. DC – The FDA has denied approval of Theratechnologies’ F8 formulation of tesamorelin, which the Canadian biotech was proposing to reduce excess abdominal fat in patients with HIV and lipodystrophy, the company announced Wednesday. In its Complete Response Letter, the regulator pointed to issues regarding tesamorelin’s chemistry, manufacturing and controls,...
ROCKVILLE, Md. — The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU) for the treatment of Graves’ disease. “After analyzing adverse event reports, the FDA has identified an increased risk of...
Washington DC – The US Food and Drug Administration (FDA) issued a warning against the purchase and use of blood glucose management product that contain glyburide and metformin according to laboratory tests. According to an FDA statement last week, Dr. Ergin’s SugarMD Advanced Glucose Support should be avoided for its...
Reata Pharmaceuticals used patient histories with trials data to win approval for new Friedreich’s ataxia drug