Federal Register Notice: FDA withdraws approval of a new animal drug application and an abbreviated new animal drug application at the sponsors reques...
FDA approves an AstraZeneca NDA for once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for treating type-2 diabetes.
FDA warns Pfizer about CGMP violations at one of its Hospira drug manufacturing facilities.
FDA warns Chinas Chongqing Pharma about data issues in producing active pharmaceutical ingredients.
FDA accepts for priority review a Teva Pharmaceutical Industries NDA for SD-809 (deutetrabenazine) for treating tardive dyskinesia.
La Jolla Pharmaceutical Co. reports positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study o...
Attorney Eric Alexander says the 6th Circuit Appeals Court correctly upheld preemption in a failure-to-warn suit brought by a woman who took an Abbott...
FDAers say the agency has the regulatory flexibility it needs to continue moving toward using a variety of evidence sources in approving drugs and sup...