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FDA publishes an International Council for Harmonization question-and-answer guidance responding to questions about its M10 bioana...[ Price : $8.95]
FDA grants accelerated approval to Bristol Myers Squibbs Augtyro to treat some adults and pediatric patients with neurotrophic tyr...[ Price : $8.95]
Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned du...[ Price : $8.95]
FDA says Revive Therapeutics should submit an IND for a clinical trial of its bucillamine as a treatment for Long Covid.[ Price : $8.95]
Federal Register notice: FDA reopens the comment period on an 11/20/2023 request for information that is intended to better unders...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Human Drug Compounding, Repackaging, a...[ Price : $8.95]
A New Jersey federal judge orders five Teva ProAir patents removed from the FDA Orange Book.[ Price : $8.95]
Two Morgan Lewis attorneys analyze a recent FDA guidance on how it will implement its drug platform technology designation program...