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...
treatment News
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
New York, NY – An iron-binding drug that is already approved for treatment of other diseases could provide a novel way to attack ovarian tumors, according to a new study led by Weill Cornell Medicine researchers. The preclinical study, which combined the analysis of human ovarian tumors and animal models...
ROCKVILLE, Md. and SHANGHAI — I-Mab (Nasdaq: IMAB) (the “Company”), a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics, and HI-Bio, a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated...
PARSIPPANY, N.J. — Ferring Pharmaceuticals announced today it is presenting the methodology for the ADSTILADRIN in BLadder cancEr (ABLE-41) Real World Evidence (RWE) study at the 20th Annual American Society of Clinical Oncologists Genitourinary Cancers Symposium (ASCO GU). ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness,...
SAN FRANCISCO, Calif. — FibroGen, Inc. announced graduation and completion of the pamrevlumab experimental arm in the Pancreatic Cancer Action Network’s (PanCAN) Precision PromiseSM Phase 2/3 adaptive platform trial, which evaluates pamrevlumab in combination with the chemotherapy treatments gemcitabine and nab-paclitaxel for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Topline...