Federal Register notice: FDA denies a request for a hearing and issues an order debarring Trang Doan Nguyen for five years from providing services in ...
FDA approves an AstraZeneca NDA for Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation designed for an improved once...
Federal Register notice: FDA determines that AstraZenecas Elavil (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 1...
FDA issues a Warning Letter to Magellan Diagnostics for modifying versions of two of its blood lead testing systems without the agencys required clear...
SCA Pharmaceuticals recalls all lots of several injectable products because there is a potential for them to contain microbial contamination.
A new analysis from the RAND Corporation says biosimilar approvals should help cut healthcare spending by $54 billion over the next decade.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Baxters Obizur is 4,216 days.
Federal Register notice: FDA makes available a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets.