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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
Beleaguered Indian generics maker Wockhardt is recalling 109,744 bottles of the hypertension drug metoprolol due to problems with how the product dissolves in the body. Read More
The FDA has rejected Novartis’ heart drug Reasanz due to minimal data on efficacy, the latest regulatory setback for the experimental treatment. Read More
Teva’s zero-hour attempt to prevent generic competition to its blockbuster multiple sclerosis drug Copaxone was halted Wednesday when a federal judge threw out its lawsuit calling for ANDA applicants to meet additional requirements. Read More