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The FDA Friday granted Merck’s Keytruda accelerated approval to treat advanced non-small cell lung cancer, making it the first PD-1 inhibitor approved for that indication. Read More
A federal judge agreed with the FDA’s interpretation that marketing exclusivity begins with NDA approval — and not the date of controlled substance scheduling — rejecting Eisai’s bid to restore exclusivity for two of its drugs. Read More
Contract manufacturer Pernix Manufacturing received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013. Read More
The Senate HELP Committee unanimously passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule to help extend their marketing exclusivity. Read More
The House Energy & Commerce Committee is once again demanding information on the status of all patients in NIH clinical trials affected by the shutdown of the agency’s drug compounding facility, despite receiving a letter from NIH saying there were no negative impacts on affected patients. Read More
The European Medicines Agency has nominated Guido Rasi as its executive director, nearly one year after he was forced to resign from the position due to a procedural issue. Read More