Biopharma FDA Prospecting Side effects 
pharmaphorum
DECEMBER 28, 2022
Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. billion buyout of Principia Biopharma.
European Pharmaceutical Review
JULY 20, 2023
More recently, the FDA granted approval of Roctavian in June 2023. She stated that some of the key concerns were around viral safety, immunogenicity and the fact that long term side effects are unknown. This included the EC’s approval of Roctavian in August 2022, which was the first gene therapy for haemophilia A.
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