US FDA’s Most Controversial Drug Approval Decisions, From A To Z
Executive Summary
With action imminent on Biogen’s Alzheimer’s drug aducanumab, the Pink Sheet looks back at 10 of FDA’s most controversial drug approval decisions, from Addyi to Zohydro.
You may also be interested in...
US FDA Neuroscience Office Director Billy Dunn Departs As Agency Faces New Review Challenges
Dunn is retiring after an 18-year career that included involvement in some high-profile and controversial drug approval decisions, not the least of which is Biogen’s Alzheimer’s treatment Aduhelm; deputy director Teresa Buracchio takes over the neurology office on an acting basis.
Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.
Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.