The US Food and Drug Administration (FDA) has granted approval for Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd, developed as TransCon hGH), a prodrug of somatropin or human growth hormone (HGH) ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

PTC Therapeutics secures FDA approval for Sephience in PKU, launching August with analysts projecting strong revenue and ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

The topical JAK inhibitor is the first treatment approved specifically for adults with moderate-to-severe chronic hand eczema.

We expect Moderna MRNA to surpass expectations when it reports second-quarter 2025 earnings on Aug. 1, before the opening ...

Genentech, part of the Roche Group ( OTCQX:RHHBY) ( OTCQX:RHHBF) ( OTCPK:RHHVF ), announced that the U.S. FDA has rejected ...

Clinical trials have shown that six-monthly injections of lenacapavir are almost 100 percent protective against becoming infected with HIV. But big questions remain over the drug’s affordability.

In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally approved for CID, to regulatory approval and commercialization for general ...