Surgery schedules around the country may be washed out for several more weeks while a crucial IV and sterile fluids factory ...

CHICAGO -- A mutation-agnostic gene therapy for retinitis pigmentosa (RP) showed promise for improving vision in severely ...

The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...

The biotech engaged with the FDA on alternative pathways to approval after seeing safety and efficacy data from the phase 1/2 ...

The FDA has granted a de novo clearance to a new type of stent designed to hold open the passages down the windpipe and into ...

HLTH 2024 features high-profile panels, offline conversations, and chatter on buzzy topics like GLP-1 and health AI.

Teva Pharmaceutical Industries (NYSE:TEVA) and Alvotech (NASDAQ:ALVO) said the FDA has expanded labeling for its biosimilar ...

The FDA issued a complete response letter (CRL) to Camurus, dealing a setback to the Swedish drugmaker’s efforts to bring its ...

Duloxetine Delayed-Release Capsules were recalled because the pills may contain high levels of a cancer-causing chemical.

The U.S. Food and Drug Administration updated the risk level of a recalled antidepressant due to the product containing high ...

The U.S. Food and Drug Administration is urging patients not to stop taking their prescribed medication if it falls under the ...

Verticals that will be most impacted by innovative developments in technology and science are the disciplines of medicine, ...