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...
FDA approves a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tract infections.
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...
Compass Pathways says it expects to be able to launch its COMP360 psilocybin treatment for treatment-resistant depression nine to 12 months sooner tha...
