Responding to a petition seeking the removal of approval for Jazz Pharmaceuticals lung cancer drug Zepzelca, FDA explains why it doesnt agree with the...
FDA gives accelerated approval to Janssens teclistamab-cqyv for some adults with relapsed or refractory multiple myeloma.
FDA medical reviewers tell members of the Cardiovascular and Renal Drugs Advisory Committee there are safety concerns with GlaxoSmithKlines anemia dru...
Federal Register notice: FDA makes available a draft guidance entitled In Vitro Release Test Studies for Topical Products Submitted in ANDAs.
FDA warns West Columbia, SC-based Nephron SC about CGMP and other violations at its drug manufacturing facility.
FDA says it is postponing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review and vote on an Ipsen Biop...
FDA warns Chatsworth, CA-based Advanced Cosmetic Research Laboratories about CGMP violations and marketing of misbranded unapproved new drugs.
FDA releases the form FDA-483 with six observations from an inspection at Indias Jubilant Generics.
