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The FDA has issued a Form 483 to a drug manufacturer and repackager in Saint Paul, Minn., for multiple deficiencies observed during a Nov. 1-18, 2021 inspection of its facility, including several that were observed during previous inspections. Read More
The FDA has issued a warning letter to Monroe Township, N.J.-based Premier Trends for online marketing of a misbranded and adulterated drug called Magic Heal, an over-the-counter blend of essential oils used to promote skin health. Read More
AstraZeneca’s checkpoint inhibitor Imfinzi (durvalumab) didn’t meet its primary endpoint of improving progression-free survival when compared with chemoradiotherapy (CRT) alone in the treatment of patients with locally advanced cervical cancer, the company said. Read More
Because its phase 3 trial was conducted only in China, the FDA has told Eli Lilly to go back to the drawing board with its promising investigational checkpoint inhibitor sintilimab for the treatment of nonsmall-cell lung cancer (NSCLC). Read More
ECI Pharmaceuticals said a warning letter it received from the FDA for listing an incorrect active pharmaceutical ingredient for its drug products was the result of a “clerical error.” Read More
India currently makes the lion’s share of active pharmaceutical ingredients (APIs), the raw materials used to create prescription drugs, for the U.S. Read More
Pfizer’s investigational once-a-day oral drug, etrasimod, has shown significant efficacy in a phase 3 study for the treatment of patients with ulcerative colitis. Read More