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 ...

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

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...

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® ...

Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...

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

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

Shares of SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) climbed 2.7%, building on a previous gain of 2%, following the FDA ...

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