FDA warns Jabil Inc. about significant CGMP violations at its Pharmaceutics International unit in Cockeysville, MD.
Novartis and Bristol Myers Squibb confirm to BioSpace that they are suspending some CAR T candidate trials to evaluate adverse events that included de...
FDA adds a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices, saying it has foun...
FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage.
IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 rial design for IDE849 for treating extensive stage small cell...
Karyopharm Therapeutics files a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitinib for patients with...
FDA and the U.S. Securities and Exchange Commission sign an MOU to strengthen cooperation and share information involving companies and products regu...
An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after missing its FDA-mandate...
