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A federal appeals court overturns a district court decision to dismiss, due to federal preemption, product liability claims under ...[ Price : $8.95]
A JAMA Oncology article discusses a collaboration between FDA, the National Cancer Institute, and patient and industry representat...[ Price : $8.95]
FDA approves a Daiichi Sankyos Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for treating patients with unresectable o...[ Price : $8.95]
FDA issues Acadia Pharmaceuticals a second complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treati...[ Price : $8.95]
Merck says it will file a response next year to an FDA complete response letter it received in January on an NDA for gefapixant an...[ Price : $8.95]
Principal deputy commissioner Janet Woodcock says the user fee impasse on Capitol Hill will likely damage ongoing recruitment effo...[ Price : $8.95]
CDRH seeks proposals for medical device site visits as part of its Experiential Learning Program, which is intended to educate the...[ Price : $8.95]
Regenxbio plans a BLA using the accelerated approval pathway for its RGX-121 Hunter Syndrome treatment.