FDA posts the latest three months of potential signals of serious risks/new safety information for prescription drug products.
Reuters reports that several major drug companies are expected to raise list prices on some 350 drugs this month.
FDA clears a Vivos Therapeutics 510(k) for its daytime-nighttime appliance for treating obstructive sleep apnea and snoring in adults.
CDER researchers discuss some of the challenges in using single-arm trials to support the approval of oncology drugs.
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.