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Italian API manufacturer Icrom was hit with a ten-item Form 483 by the FDA for serious quality violations at its facility in Concorezzo, north east of Milan. Read More
Mylan was hit with an FDA warning letter for serious GMP violations at an API manufacturing facility in Andhra Pradesh, India, including improper handling of raw materials. Read More
Another Duchenne muscular dystrophy gene therapy trial has been held up by the FDA following a serious adverse event in one patient. The agency halted Solid Biosciences’ trial of SGT-001 twice before due to reported serious adverse events. Read More
AstraZeneca and Nektar Therapeutics hit Aurobindo with a patent infringement suit in a Delaware federal court over Aurobindo’s generic version of their constipation drug Movantik (naloxegol). Read More
EU investigators found serious deficiencies in aseptic manufacturing during an inspection of the NCPC Hebei Huamin facility in Shijiazhuang, Hebei province. Read More
Regenxbio is challenging in federal court the FDA’s recent decision to place holds on the company’s two trials for retinal disease therapies, saying the agency did not follow its own regulations in handling the matter. Read More