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FDA reviewers raise concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of...[ Price : $8.95]
FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot ped...[ Price : $8.95]
FDA warns Hiram, GA-based VasoCorp Inc. that it is illegally marketing misbranded unapproved new drugs.[ Price : $8.95]
The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative ...[ Price : $8.95]
FDA issues a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing ...[ Price : $8.95]
FDA posts 17 revised draft product-specific guidances for peptide products, which it touts as a significant advancement in the age...[ Price : $8.95]
FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatm...[ Price : $8.95]
FDA releases the 17-page form FDA-483 following a May inspection at Indias Strides Pharma Science drug manufacturing facility in B...