Avid Bioservices Inc (CDMO)

[BioBS2012]

Will PPHM make it one day? Another BTD granted for those keeping score

FDA Grants Breakthrough Status To Factor Xa Inhibitor Antidote– Portola Pharmaceuticals said that the FDA had granted a breakthrough therapy designation for its investigational Factor Xa inhibitor, andexanet alfa. The designation is intended “to expedite the development and review of drugs for serious or life-threatening conditions,” according to the FDA, which requires “preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.”