A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vinay Prasad.
FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocerebellar ataxia.
FDA issues a Warning Letter to Apotex, citing significant GMP violations at the companys Richmond Hill, Ontario, facility, including failures in steri...
FDA warns Waunakee, WI-based Scientific Protein Laboratories about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Politico reports that President Trump and HHS are standing by FDA commissioner Marty Makary as the agency weathers the sudden departure of CDER direct...
Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.
An Axios report following the resignation of CDER director George Tidmarsh questions how much more agency dysfunction industry can accept before simpl...
Sarepta Therapeutics reports mixed data from its Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy drugs Amondys 45 (casim...
