FDA clears a Neocis Inc. 510(k) for Yomi, a robotic guidance system for dental implant procedures.
Juno Therapeutics halts development of its CAR-T cell product candidate JCAR015, indicated for relapsed or refractory B cell acute lymphoblastic leuke...
GAO says FDA should develop a guidance to help antibiotic drug sponsors under the qualified infectious disease product designation and its incentives.
FDA accepts a Dynavax Technologies submission that addresses an 11/2016 Complete Response Letter for its BLA for Heplisav-B [hepatitis Bb vaccine, rec...
Attorney Michelle Yeary says that a Pennsylvania court erred in ruling that a medical device strict liability case could proceed.
FDA and the EU finalize a mutual recognition agreement to allow drug inspectors to rely on information from inspections each party conducts.
Indias Money Control Web site reports that Morton Grove Pharmaceuticals, a Wockhardt subsidiary, has received an FDA Warning Letter.
Gilead asks FDA for five-year NCE exclusivity for its Stribild and two other products under a court ruling rejecting the agencys NCE exclusivity polic...