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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.

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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.

The Short And Controversial Life Of Zohydro Comes To An End

US FDA’s approval of the opioid over resounding opposition of an advisory committee has haunted the agency, and it has imperiled both of Robert Califf’s nominations to be commissioner. The latest company to own Zohydro stopped selling it and FDA withdrew approval of its NDA.

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