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The FDA’s Office of Planning is calling for better coordination and communications between CDER and CDRH to facilitate reviews of a growing tide of combination therapies. Read More
A federal appeals court refused to rehear the biosimilars case pitting Sandoz against Amgen, letting stand a July decision allowing Sandoz to launch its Zarxio biosimilar of Amgen’s cancer therapy Neupogen (filgrastim) in September. Read More
An Alabama compounder is recalling all of its nonexpired drug products over possible contamination issues and stopped production of sterile compounds after the FDA received reports of adverse events. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif., manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
A consumer watchdog group is urging the FDA to hold drugmakers to a higher standard when it comes to data to support NDAs, saying the agency’s review of Boehringer Ingelheim’s blockbuster bloodthinner Pradaxa was flawed and dangerous. Read More