Bristol Myers Squibb decides to withdraw a 2011 indication granted to subsidiary Celgene under accelerated approval for Istodax (romidepsin), a histon...
FDA warns Farmakeio Outsourcing about violations at its Texas drug facility.
FDA accepts a Genentech sBLA for a new indication for Tecentriq and grants it priority review.
Philips Respironics recalls its V60 and V60 Plus ventilators that provide High Flow Therapy, due to a risk to the patients if the system pressure reac...
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority--21 CFR Part 810.
Federal Register notice: FDA extends the comment period for a 6/4 notice about a draft guidance entitled Enhanced Drug Distribution Security at the Pa...
FDA warns Syntec Pharma about CGMP deviations in its production of active pharmaceutical ingredients.
FDA clears an Abbott 510(k) for its latest optical coherence tomography (OCT) imaging platform powered by the companys new Ultreon Software.