FDA approves Gileads Sunlenca, the first in a new class of drugs to treat some HIV-1 patients.
FDA publishes a technical conformance guide for its guidance on the format and content of a REMS document.
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.
