U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for ...

SAN DIEGO, May 01, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment ...

The FDA plans to gather information from 250 compounding outsourcing pharmacies amid safety and quality concerns. In a May 1 notice, the agency said it will survey outsourcing facilities about ...

The Food and Drug Administration is again trying to rehire some staffers who were recently fired amid mass layoffs at the agency.

The FDA granted fast track designation to urcosimod to treat neuropathic corneal pain, according to a press release from Okyo Pharma. Urcosimod, formerly called OK-101, is a “lipid conjugated chemerin ...

No, red dye 3 and red dye 40 are not the same. Red dye 40, made of a chemical compound called Allura red AC, is already ...