Psychedelic care faces a U.S. delivery test
More than 80 speakers joined an FDA discussion of psychedelic therapies. The hearing exposed a practical gap between regulatory attention and the systems needed to deliver treatment safely.
FDA & Regulatory Affairs 4 articles
FDA & Regulatory Affairs follows the formal regulatory work required to move biotechnology products through development and review in the United States. Investigational applications, agency guidance, meetings, marketing submissions, labeling and postmarketing obligations are interpreted in relation to product evidence and development strategy. Clinical results belong here only when the regulatory consequence is central; trial methodology and efficacy interpretation remain under Clinical Trials & Evidence.
FDA Clears First CLEC2A CAR T Trial for AML
The FDA has cleared a first-in-human CLEC2A CAR T study at three U.S. centers. Researchers will test whether the target can spare normal blood-forming cells.
T-MAXIMUM Reports FDA Clearance for MT027 Brain Study
T-MAXIMUM says the FDA cleared a Phase 2 study of MT027 for brain metastases from lung and breast cancer. The reported clearance has not been independently confirmed, and it does not establish the therapy’s safety or efficacy.
FDA clears Hovilpri for refractory HSV in immunocompromised adults
The FDA approved Hovilpri on October 9, 2026, for immunocompromised adults with HSV lesions that resist standard antivirals, whether or not resistance is confirmed. The decision follows Asahi Kasei’s $920 million acquisition of AiCuris.