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British authorities are ordering an Indian manufacturer to recall batches of progesterone injections after an inspection turned up one critical GMP violation and three major ones at one of its facilities. Read More
The FDA has handed Boehringer Ingelheim a 10-observation Form 483 for delays with a field alert report, as well as sanitation and sterilization procedures at a site in Germany. Read More
The UK’s drug pricing watchdog has recommended reimbursement of Novartis’ innovative drug Cosentyx for ankylosing spondylitis, but only if it provides it at a discount. Read More
In the absence of industry pushback, an FDA final rule on manufacturing procedures and dating processes for biologics will take effect as planned on Sept. 16. Read More
The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies. Read More
Industry continues to be divided on whether to include interchangeability statements on biosimilar labels, with Amgen taking the lead in support and Merck taking the lead against in comments on the FDA’s March draft biosimilar labeling guidance. Read More
Two FDA advisory committees recommend the approval of Egalet's opioid Arymo to manage severe pain that requires daily, long-term treatment when alternatives are unavailable, with three abuse-deterrent labels. Read More