FDA clears a BioStable Science & Engineering 510(k) for the HAART 300 Aortic Annuloplasty device, an internal annuloplasty device designed for aortic ...
FDA grants Genentech a breakthrough therapy designation for Rituxan (rituximab) and its use for treating pemphigus vulgaris, a rare, serious and life-...
Eli Lilly says it will invest $850 million in its U.S. operations in 2017 to expand its U.S. research laboratories, manufacturing sites, and general a...
FDA approves a Shionogi Inc. and Purdue Pharma NDA for Symproic (naldemedine) 0.2 mg tablets, a once-daily oral peripherally-acting mu-opioid receptor...
FDA licenses eight Quotient Limited rare antisera blood typing reagent products that are intended for use in transfusion diagnostics, and formulated s...
An Alliance for a Stronger FDA analysis says President Trumps budget blueprint, which includes a doubling of user fees, will likely be dead on arrival...
An LA Times article says that a recent medical device reports link a superbug outbreak at a foreign health facility to a duodenoscope that Olympus mod...
FDA accepts for review a Symbiomix NDA for its lead investigational product candidate Solosec (secnidazole oral granules), an antibiotic designed to t...