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Latest From Amylyx Pharmaceuticals, Inc.

House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval

Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.

User Fees Legislation

Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News

CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Mitsubishi’s Oral Radicava Provides Convenience Option For ALS

Oral or feeding tube administration of the cerebral neuroprotectant should offer flexible dosing options for amyotrophic lateral sclerosis patients, the firm says.

Approvals Business Strategies

US FDA Advisory Committees As The Court Of Appeals

The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.

Advisory Committees Drug Review
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