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The FDA and European Medicines Agency took differing views on multiple melanoma injections up for approval, with the U.S. agency rejecting Spectrum Pharmaceuticals’ Evomela and the EMA’s scientific experts recommending approval of Amgen’s Imlygic. Read More
The FDA Friday approved Alexion Pharmaceuticals’ Strensiq for the first-ever treatment of hypophosphatasia, a rare genetic metabolic disorder that weakens bones. Read More
FDA’s Office of Manufacturing Quality will now be involved in evaluating all BLAs and supplements to ensure product quality throughout a product’s lifecycle. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
The FDA cited Novartis’ Vaccines and Diagnostics facility in Liverpool, UK, for lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11. Read More
The FDA could issue guidance on demonstrating interchangeability between a biosimilar and its reference product by the end of the first quarter of next year. Read More