FDA grants Ideaya Biosciences a breakthrough therapy designation for darovasertib for neoadjuvant use in adult patients with primary uveal melanoma.
FDA issues a complete response letter to Aldeyras NDA for reproxalap to treat dry eye disease, citing a lack of efficacy in the submitted trial.
FDA Webview Contributing Editor John Hope says the dismissal of agency communications staff will hurt information flow to the public.
Former FDA commissioner Scott Gottlieb predicts just-confirmed FDA commissioner Marty Makary will soon face political interference from the Trump admi...
FDA grants orphan drug designation to Sanofis investigational drug rilzabrutinib for two rare diseases.
NYU Langone Health researchers say they better understand the role the BRAC 2 cancer gene plays in helping repair DNA in cancer cells.
Realizing that essential FDA staff have been fired, the agency asks some employees to return for 60 days to assist in the transition to a new staffing...
BeiGene scraps the development of BGB-A1217 (ociperlimab), an anti-TIGIT antibody, as a potential treatment for lung cancer.
