FDA | DAILYZ HEALTH NEWS

FDA clears first gene-edited cell therapy for severe sickle cell disease, paving way for wider use of CRISPR-based treatments in US hospitals

The FDA approved CASGEVY™, the first CRISPR gene-edited cell therapy, for severe sickle cell disease patients 12 and older with recurrent crises.

As of mid-2026, the FDA has not approved any gene-editing therapies for type 1 diabetes, with such treatments still in preclinical stages.

The FDA has not approved RebiQuent for moderate to severe atopic dermatitis; current oral treatments include abrocitinib and upadacitinib.

The FDA warns against counterfeit semaglutide injections sold online after severe adverse events linked to fake Ozempic products.

Federal health officials prepare new FDA and HHS actions in 2024 amid debates on mifepristone, vaccines, and psychedelic medicine policies.

The FDA will reconsider Atara Biotherapeutics’ rare cancer drug Ebvallo after initially rejecting it due to manufacturing concerns.

President Trump signed an executive order to expedite FDA approval of psychedelic drugs for serious mental illness treatment in the U.S.

The FDA and CMS launched the RAPID pathway to speed Medicare coverage decisions for breakthrough medical devices through aligned reviews.

The Justice Department reclassified cannabis as Schedule III, allowing FDA-approved medical marijuana research and expanded treatment options.

The FDA approved the Lumipulse G pTau217/ß-Amyloid 1-42 blood test for early Alzheimer’s detection in adults 55+ with cognitive decline.