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FDA approves an Incyte supplemental NDA for Jakafi (ruxolitinib) for treating chronic graft-versus-host disease after failure of o...[ Price : $8.95]
The Medical Imaging & Technology Alliance says an FDA draft guidance on medical device remanufacturing is not likely to be effecti...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a B. Braun Medical ANDA for 6% hydroxyethyl starch after the company requested ...[ Price : $8.95]
Federal Register notice: FDA announces an 11/2 virtual public meeting to discuss proposed recommendations for reauthorizing the Bi...[ Price : $8.95]
FDA grants a de novo marketing authorization for Paige AIs Paige Prostate software that is intended to assist pathologists in dete...[ Price : $8.95]
FDA defers a review action on an Alvotech BLA for AVT02, the companys proposed biosimilar of AbbVies Humira (adalimumab) Humira, u...[ Price : $8.95]
Two Hyman, Phelps attorneys analyze the top 10 things they like in the FDA PUDFA 7 goals letter.[ Price : $8.95]
Researchers writing in the Annals of Internal Medicine say FDA must find ways to improve institutional memory of drug review decis...