Federal Register notice: CDERs Office of Prescription Drug Promotion proposed to conduct a study on Perceptions of Prescription Drug Products with Me...
Federal Register notice: FDA sends OMB an information collection extension entitled Certification of Identity for Freedom of Information Act and Priva...
With the 5/2 posting of five deemed final orders, FDA completes the process of posting 33 deemed final orders that was part of over-the-counter drug m...
FDA issues a partial clinical hold on Sun Pharmas Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia areata.
Federal Register notice: FDA announces a 6/14 public workshop entitled FDA Science Forum 2023.
FDA approves a Medtronic PMA for its Micra AV2 and Micra VR2 next-generation miniaturized, leadless pacemakers.
Astellas Pharma and Pfizer plan to discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for use in men with non...
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) that seeks an expanded indication to include ...
