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

The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...

Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® ...

In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...

Approval makes Gomekli the first treatment to be approved for both adults and pediatric patients for neurofibromatosis type 1 ...

The 5 mg risdiplam tablet provides the same efficacy and safety for spinal muscular atrophy as the currently available oral ...

Pfizer hopes a unique life-extension benefit for its Talzenna can serve to further expand the drug’s already ...

Acadia Pharmaceuticals' forecasted revenues top $1bn in 2025. Find out why ACAD stock is a "Buy" with its profitable outlook ...

Hims & Hers hit the bullseye with its Super Bowl ad, sparking a surge in clicks to its site.The ad also hit a nerve with the ...

Leaked data showed that Pfizer’s mevrometostat has strong therapeutic potential in metastatic castration-resistant prostate ...

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...