Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

The ad goes on to tout Hims & Hers' weight loss drugs as less expensive alternatives to medications like Ozempic and Wegovy, ...

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Lately, one of America's leading pharmaceutical companies can't catch a break from Wall Street. Shares of Vertex ...

If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...

Ryoncil ® was approved in December 2024 by the United States Food and Drug Administration (FDA) for steroid-refractory acute ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

Previously, the drug was approved by the MHRA to treat advanced ... The partners expect the FDA to complete its review process in the fourth quarter of 2025. Simponi was first approved in 2009 ...

Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...