FDA News

SHANGHAI--(BUSINESS WIRE)--YolTech Therapeutics, a late clinical-stage biotechnology company developing in vivo gene-editing therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for YOLT-202, the company’s investigational in vivo base-editing therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). The FDA approval enables the initiation of an open-label, single-dose expansion Phase 2/3 clinical study...

PHILADELPHIA--(BUSINESS WIRE)--GSK’s RSV vaccine, AREXVY, approved in US for expanded age indication in adults aged 18–49 years at increased risk...

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that members of the Company’s management team will participate in a virtual fireside chat at the Stifel 2026 Virtual CNS Forum on March 17, 2026 at 12:00pm ET. The presentation will be accessible via a live webcast on the Events and Presentations page in the Investo...

NATICK, Mass.--(BUSINESS WIRE)--Allurion Technologies, Inc. (the “Company”) (OTCID: ALUR), a pioneer in metabolically healthy weight loss, announced today that it has appealed the decision by the New York Stock Exchange (the “NYSE”) to initiate delisting proceedings against Allurion’s securities pursuant to Section 802.01B of the NYSE’s Listed Company Manual, which requires listed companies to maintain an average global market capitalization over a consecutive 30 trading day period of at least...

ACTON, Mass.--(BUSINESS WIRE)--Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S....

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam Reports Fourth Quarter and Full Year 2025 Results...

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and a leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, today announced that data for adrabetadex, an investigational cyclodextrin-based therapy in development for infantile-onset Niemann-Pick disease type C (NPC), were presented at the 2026 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting in Baltimore, MD. The presentation i...

CUMBERLAND, R.I.--(BUSINESS WIRE)--Neurotech Pharmaceuticals, Inc. (the “Company”) today provided an update on its ongoing transition to a commercial‑stage company following the first anniversary of the FDA’s approval of ENCELTO™ (taroretcel-lwey), the Company’s encapsulated cell‑based gene therapy for adults with idiopathic Macular Telangiectasia Type 2 (MacTel). ENCELTO continues to be integrated into retina practices nationwide, supported by expanding access and established commercial manufa...

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel)...

DOVER, Del. & EPALINGES, Switzerland--(BUSINESS WIRE)--Pilatus Biosciences Announces First Patient Dosed in Phase 1 Trial of First-in-Class Metabolic Checkpoint Antibody PLT012 in Solid Tumors...