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October 16, 2017
Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.
The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.
October 13, 2017
The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.
October 11, 2017
Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.
AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
FDA published guidance on the format and content of REMS documents.
October 05, 2017
FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.