The proposal could affect telehealth services that rely on outside facilities to produce the knockoff drugs in bulk.

Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...

VEPPANU™ is the first-and-only FDA-approved PROTAC, a type of heterobifunctional protein degrader –– Approval received in advance of ...

The US FDA has proposed an end to most types of compounding of semaglutide, tirzepatide, and liraglutide. The agency said in a statement it has determined there is no longer a clinical need for ...

Arvinas and Pfizer are the first to take a PROteolysis TArgeting Chimera (PROTAC) therapy across the FDA finish line, opening ...

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can ...

The FDA has granted 510(k) clearance to Zeta Surgical's AI-assisted Zeta Navigation System and its navigated instruments, enabling millimeter-level, real-time image guidance for brain tumor biopsies ...

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

The FDA released findings from its largest test on infant formula, focused on chemical contaminants and overall safety.

Second Nature Brands has issued a recall of its Keto Crunch Smart Mix on Friday after discovering the product may contain ...