FDA approves an Exelixis NDA for Cabometyx (cabozantinib) for treating certain adult and pediatric patients 12 years of age and older with locally adv...
FDA approves an Incyte supplemental NDA for Jakafi (ruxolitinib) for treating chronic graft-versus-host disease after failure of one or two lines of s...
The Medical Imaging & Technology Alliance says an FDA draft guidance on medical device remanufacturing is not likely to be effective until the agency ...
Federal Register notice: FDA withdraws approval of a B. Braun Medical ANDA for 6% hydroxyethyl starch after the company requested such.
Federal Register notice: FDA announces an 11/2 virtual public meeting to discuss proposed recommendations for reauthorizing the Biosimilar User Fee Ac...
FDA grants a de novo marketing authorization for Paige AIs Paige Prostate software that is intended to assist pathologists in detecting areas that are...
FDA defers a review action on an Alvotech BLA for AVT02, the companys proposed biosimilar of AbbVies Humira (adalimumab) Humira, until manufacturing f...
Two Hyman, Phelps attorneys analyze the top 10 things they like in the FDA PUDFA 7 goals letter.