FDA approves a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea and vomiting in adul...
Federal Register notice: FDA releases a final guidance entitled Q3D(R2) Guideline for Elemental Impurities.
Federal Register notice: FDA determines that intramuscular antibiotic bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn...
Akorn pays $7.9 million to resolve allegations that it caused Medicare to submit false claims by delaying an Rx to OTC switch for three generic drugs.
A MasterControl white paper lists the processes involved in the most common FDA medical device observations and Warning Letters.
FDA grants in part and declines in part a Catalyst Pharmaceuticals petition on using amifampridine to treat congenital myasthenic syndromes.
Novartis asks FDA not to approve ANDAs seeking to produce a generic form of its Entresto under specific conditions.
Federal Register Notice: FDA announces an 11/1 Advisory Committee meeting to discuss ongoing concerns that pulse oximeters may be less accurate in cer...
