FDA releases the FDA-483 with eight inspection observations from a recent inspection at Indias Biocon Limited.
Two Epstein Becker Green attorneys say new FDA commissioner Scott Gottlieb is likely to meet three coming 21st Century Cures Act deadlines.
Coherus Biosciences asks FDA to deny an Apotex petition on a Neulasta biosimilar because it contains erroneous information on the role of clinical tri...
The Senate Health, Education, Labor & Pensions Committee votes 21-2 to advance S. 934, the FDA Reauthorization Act of 2017, that would reauthorize FDA...
FDA clears a NxStage Medical 510(k) for its next generation hemodialysis system, NxStage System One.
FDA clears an NDS 510(k) for its new ZeroWire Mobile battery-powered display stand solution, which is intended to enable untethered clinical mobility ...
FDA grants accelerated approval for Mercks Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and carboplatin, for first-line treatment ...
FDA warns Indiana University School of Medicines Merrill Benson about objectionable conditions at a clinical trial of an investigation drug for which ...