The firm submitted data showing that more than 70 percent of patients with HER2-mutated NSCLC who hadn't received anti-HER2 therapy responded to sevabertinib.

requires review of a comprehensive data package submitted by the drug sponsor that includes critical analytic similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical ...

"We're looking at an FDA and scientific review staff that is stable, engaged and meeting its deadlines," Sebastian Guth, who oversees Bayer's U.S. operations, said in an interview. Guth said that ...

Bayer US Head Says FDA Chief Reassured Pharma Executives of Timely Reviews NEW YORK (Reuters) - Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently ...

across all FDA centers by June 30 in a bid to speed up the review process of new drugs. The decision comes after the successful completion of an AI-assisted scientific review program as a pilot ...

FDA has granted full approval to Bayer’s larotrectinib (brand name Vitrakvi), a first-in-class tropomyosin receptor kinase (TRK) inhibitor, for treatment of solid tumors in both adult and pediatric ...

The U.S. Food And Drug Administration (FDA) granted full approval to Bayer AG’s (OTC:BAYRY) Vitrakvi (larotrectinib) for adult and pediatric patients with solid tumors that have a neurotrophic ...