The FDA delays its decision on Biogen's controversial pitch on its Alzheimer's drug — and the biotech's shares soar
Usually, a 3-month delay on a PDUFA deadline is unwelcome news at a biopharma company. For Biogen $BIIB, it’s manna from heaven.
The big biotech reported Friday morning that the FDA has called for a 3-month delay on its March PDUFA deadline for the Alzheimer’s drug aducanumab. According to the company, Biogen and its partners at Eisai have supplied additional information to the FDA that the agency has deemed a major amendment that requires added time to study.
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