[ Price : $8.95]
FDA and Vanda agree to a series of actions to resolve their disputes over the companys Hetlioz and tradipitant.[ Price : $8.95]
A CDRH Learn module reviews the Quality Management System Regulation requirements for medical device manufacturers and the benefit...[ Price : $8.95]
FDA issues 17 new and 64 revised product-specific guidances to aid in developing generic drugs.[ Price : $8.95]
FDA grants Umoja Biopharma a fast track designation for its investigational therapy UB-VV111 for treating relapsed or refractory l...[ Price : $8.95]
FDA issues a complete response letter to Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, regarding their...[ Price : $8.95]
FDA approves a Novartis NDA for Rhapsido (remibrutinib), a Brutons tyrosine kinase inhibitor for treating adults with chronic spon...[ Price : $8.95]
CDRH releases a list of 11 final and draft guidances it plans to issue in FY 2026 if resources permit.[ Price : $8.95]
FDA commissioner Marty Makary tells employees affected by the government shutdown that the agency will continue mission-critical a...