Washington Legal Foundation says the 1st Circuit Appeals Court should reverse a lower court decision granting standing to bring suit to four unions wh...
FDA approves an Otonomy NDA for Otiprio (ciprofloxacin otic suspension) 6% for treating acute otitis externa (swimmers ear) caused by Pseudomonas aeru...
FDA clears a Corindus Vascular Robotics 510(k) for what the company says is the first automated robotic movement designed for its CorPath GRX platform...
An online post from Friends of Cancer Research chair and founder Ellen V. Sigal says that pending right-to-try legislation in Congress is an ill-advis...
Federal Register notice: FDA makes available a draft guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obliga...
Federal Register notice: FDA seeks comments on post-marketing pediatric-focused safety reviews of products posted between 10/23/2017 and 3/16 on its W...
An FDA review of cancer drugs that used the accelerated approval program finds that very few of the resulting indications failed to verify clinical be...
CDER promotes Office of Strategic Programs director Theresa Mullin to a new position in Center director Janet Woodcocks immediate office associate di...