An FDA payroll system error causes a paycheck delay for some FDA employees who are designated to continue working during the ongoing government shutdo...
FDA approves Bayers Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms associated with menopause.
FDA sends Sydnexis a complete response letter for SYD-101, a low-dose atropine eye-drop candidate intended to slow disease progression in children wit...
FDA grants Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use in treating cholangiocarcinoma defined by NRG1 g...
Tango Therapeutics reports that new data from its ongoing Phase 1-2 study of vopimetostat (TNG462) showed early signs of efficacy across multiple MTAP...
A ProPublica investigative report faults FDA for blocking information about foreign-made generic drugs that could help patients, doctors, and pharmaci...
The CDER Office of New Drugs publishes a MAPP on the regulatory basis for refusing to file an NDA, sNDA, BLA, or sBLA.
FDA publishes the checklists used by CDER reviewers to determine if an NDA or BLA can be accepted for filing.
