Washington Legal Foundation asks the Supreme Court to reverse a California appeals court decision that hit Ethicon with $300 million in civil penaltie...
FDA gives accelerated approval to Genentechs Lunsumio to treat some forms of follicular lymphoma.
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.
