[ Price : $8.95]
Federal Register notice: FDA announces a 9/22 Advisory Committee meeting to review a Rebiotix BLA for Rebyota (fecal microbiota, l...[ Price : $8.95]
FDA raises efficacy concerns about Reata Pharmaceticals May-submitted NDA for omaveloxolone, indicated for treating patients with ...[ Price : $8.95]
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...