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

ADAR1 Capital Management, LLC (together with its affiliates, "ADAR1" or "We"), the largest stockholder of Keros Therapeutics ("Keros" or the "Company") with approximately 13.3% of the Company's ...

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company ...

Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry ...

"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 ...