FDA issues Acadia Pharmaceuticals a second complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations an...
Merck says it will file a response next year to an FDA complete response letter it received in January on an NDA for gefapixant and its use for treati...
Principal deputy commissioner Janet Woodcock says the user fee impasse on Capitol Hill will likely damage ongoing recruitment efforts to bring onboard...
CDRH seeks proposals for medical device site visits as part of its Experiential Learning Program, which is intended to educate the Center on how new t...
Regenxbio plans a BLA using the accelerated approval pathway for its RGX-121 Hunter Syndrome treatment.
FDA issues a Form FDA-483 to Aurobindo Pharma, citing three observations after investigators inspected the firms Unit XI, an active pharmaceutical ing...
The 7th Circuit Court of Appeals affirms a lower court decision dismissing a suit charging that AbbVies filing of 132 additional Humira patents violat...
Federal Register notice: FDA seeks comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling change...
