FDA clears a Quidel 510(k) to market its Solana C. difficile Assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed ...
FDA issues Torrent Pharmaceuticals a four-item Form 483 following an inspection last month at the firms drug manufacturing facility in Indrad, Gujarat...
Scott Gottlieb officially starts as the new FDA commissioner after being sworn in by HHS secretary Tom Price.
FDA authorizes the use of Cook Medicals Flourish Pediatric Esophageal Atresia Anastomosis, a device to treat infants up to one year old for a birth de...
Holding some hope for a Trump Administration change of heart, the Alliance for a Stronger FDA calls its proposed 37% FDA budget cut in 2018 a non-star...
FDA grants Loxo Oncology an orphan drug designation for larotrectinib for treating solid tumors with NTRK-fusion proteins, which are genetic abnormali...
AstraZeneca and MedImmune announce positive results from their Phase 3 PACIFIC trial, a randomized, double-blinded, placebo-controlled trial of Imfinz...
Alzheimers disease researchers urge FDA to clarify and modernize its current approach for approving new treatments for Alzheimers.