FDA raises efficacy concerns about Reata Pharmaceticals May-submitted NDA for omaveloxolone, indicated for treating patients with Friedreichs ataxia....
A federal appeals court overturns a district court decision to dismiss, due to federal preemption, product liability claims under the Connecticut Prod...
A JAMA Oncology article discusses a collaboration between FDA, the National Cancer Institute, and patient and industry representatives that has develo...
FDA approves a Daiichi Sankyos Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for treating patients with unresectable or metastatic HER2-lo...
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...
