Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...

Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis ...

The FDA approved the first drug in its class that targets moderate to severe acute pain in adults, without being addictive ...

It could be a real game-changer for managing pain. Researchers at UW Medicine say a new pain relief drug was just approved by ...

A new FDA approval stands to give Daiichi ... noncancerous growth that affect the joints. The drug, now known under the brand name Romvimza, is approved for TGCT cases in which surgery would ...

The FDA on Tuesday signed off on SpringWorks Therapeutics’ mirdametinib—now to carry the brand name Gomekli—for the treatment ...

Nuvation has a best-in-class lung cancer drug that could be approved in the US in June. Read why I'm bullish on the stock ...

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

Italian biotech Cassiopea has won US approval ... as the current drugs used to treat acne are all very cheap, but the overall market represents multibillion dollars per year, and Cassiopea ...

Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application ...

An official who oversees a team at the Food and Drug Administration that reviews Neuralink Corp. devices was fired, according ...

Daiichi Sankyo’s pexidartinib has become the first FDA-approved ... backed the drug at a meeting in May. TGCT is diagnosed in an estimated 11 people per million in the US each year, so is ...