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Novartis wants the FDA to back off plans that would require drugmakers to include details of clinical trials data in labeling for drugs brought to market under accelerated approval pathways. Read More
The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based. Read More
Chicago-based Durata Therapeutics won FDA approval for Dalvance, an antibacterial for skin infections that is the first drug approved under the Qualified Infections Disease Product designation, the agency said Friday. Read More
Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
The FDA has approved Japanese drugmaker Takeda Pharmaceutical’s biologic injection Entyvio to treat adults with moderate to severe ulcerative colitis or Crohn’s disease. Read More
Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
GlaxoSmithKline’s efforts to expand the indication for its cancer drug Arzerra were dashed when the drug failed to meet its primary endpoint in a Phase III trial. Read More