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Onyx Pharmaceuticals, Inc.

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Latest From Onyx Pharmaceuticals, Inc.

The Quality Lowdown: The Warning Letter Monsoons That Might Follow The Inspection Drought

Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.

Manufacturing Quality

US FDA’s Most Controversial Drug Approval Decisions, From A To Z

Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the FDA’s most controversial drug approval decisions, from Addyi to Zohydro.

Approvals Drug Approval Standards

The Ups And Downs Of Aducanumab’s Rollercoaster Development Program

The Biogen Alzheimer’s product saw its ‘likelihood of approval’ score from Biomedtracker change directions multiple times as it moved through clinical trials and US FDA review.

Approvals Drug Review

US FDA’s Most Controversial Drug Approval Decisions, From A To Z

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.

FDA Drug Approval Standards
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