Jet Medical and two related companies agree to pay $700,000 to resolve criminal and civil charges involving Jets distribution of unapproved medical de...
Checkpoint Therapeutics files a BLA for cosibelimab, an investigational anti-PD-L1 antibody for treating patients with metastatic cutaneous squamous c...
FDA updates the CDRH Recognized Consensus Standards database, adding List 59.
FDA modifies the mifepristone REMS to remove the in-person dispensing requirement and permit dispensing by certified pharmacies.
In addition to a $226 million boost in FDA spending levels, the year-end omnibus spending bill also includes notable agency reforms that were once par...
FDA says Accord Healthcare recalled one lot of daptomycin for injection due to a labeling mix-up.
FDA approves a resubmitted Acer Therapeutics NDA for its Olpruva to treat some patients with urea cycle disorders.
FDA warns The Woodlands, TX-based RoyalVibe Health about manufacturing, marketing, and distributing unapproved medical devices that are misbranded and...
