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.
Bluebird Bio says it is working to resume enrollment and treatment of patients ages 2-17 in a lovo-cel sickle cell clinical trial after FDA lifts a pa...
Attorney Phyllis Marcus says an updated Federal Trade Commission compliance guidance covers dietary supplements and adds many additional health-relate...
FDA warns Hanover, PA-based MD Pharmaceutical Supply about CGMP deviations in its drug repackaging and relabeling operations.
FDA warns Brazils Nortec Quimica about CGMP deviations in its production of active pharmaceutical ingredients.
