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Federal Register notice: FDA corrects a 4/12 notice about a final guidance entitled A Risk-Based Approach to Monitoring of Clinica...[ Price : $8.95]
Federal Register notice: FDA creates a public docket to collect comments on methodological challenges related to patient experienc...[ Price : $8.95]
Federal Register notice: CDERs Office of Prescription Drug Promotion proposed to conduct a study on Perceptions of Prescription D...[ Price : $8.95]
Federal Register notice: FDA sends OMB an information collection extension entitled Certification of Identity for Freedom of Infor...[ Price : $8.95]
With the 5/2 posting of five deemed final orders, FDA completes the process of posting 33 deemed final orders that was part of ove...[ Price : $8.95]
FDA issues a partial clinical hold on Sun Pharmas Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia ...[ Price : $8.95]
Astellas Pharma and Pfizer plan to discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for...[ Price : $8.95]
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) that seeks an expanded in...