FDA News

EVANSTON, Ill.--(BUSINESS WIRE)--Flashpoint Therapeutics, a biotechnology company pioneering the development of transformative nanomedicines, proudly congratulates its founder, Professor Chad A. Mirkin, on being named the recipient of the 2027 Priestley Medal by the American Chemical Society (ACS). This accolade stands as the premier distinction in the field of chemistry, celebrating Prof. Mirkin’s sweeping innovations in nanotechnology and his distinguished service to the global scientific com...

SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to remlifanserin, an investigational, highly selective, 5-HT2A receptor inverse agonist, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions a...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the apitegromab marketing authorisation application (MAA) for children and adults with spinal muscular atrophy (S...

MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke, today announced that on July 15, 2026, it granted options to purchase an aggregate of 160,000 shares of DiaMedica’s common stock to a newly hired non-executive employee whose employment commenced in July 2026. The stock options were a material inducement to the employee’s...

ENGLEWOOD, N.J.--(BUSINESS WIRE)--When breast cancer is caught while it is still confined to the breast, the five-year relative survival rate is about 99%. Once it has spread to distant parts of the body, that figure falls to roughly 31%, according to the National Cancer Institute. SpotitEarly is working to move far more patients into that first group with a screening test as simple as breathing into a mask. Today, the multi-cancer early-detection company announced a strategic partnership with...

BEDFORD, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. The Company today announced that, effective on July 15, 2026, it granted stock options to purchase shares of common stock to Thomas McCauley, the Company’s...

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, shared recommendations for strengthening the United States as a leading destination for early clinical development during the U.S. House Committee on Energy and Commerce Subcommittee on Health hearing, “Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role in Advan...

CHICAGO--(BUSINESS WIRE)--Tempus, a technology company leading the adoption of AI to advance precision medicine, today highlighted results of the Articulate Pro study, published in Nature Digital Medicine, evaluating the use of AI to assist pathologists in prostate biopsy reporting. The study was a real-world evaluation of the Paige Prostate Suite, an integral part of the Tempus intelligent diagnostics ecosystem, and its integration into routine clinical workflows. AI-assisted review supported...

FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol) for the treatment of pediatric patients (at least 26 weeks of gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia (HABP...

BOSTON & MONTREAL--(BUSINESS WIRE)--enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced changes to its Board of Directors as it plans for potential regulatory milestones and to support commercial readiness for detalimogene voraplasmid (“detalimogene”) if approved. Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk no...