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ARS Pharmaceuticals, Inc.

https://ars-pharma.com/

Latest From ARS Pharmaceuticals, Inc.

Deal Watch: AbbVie Pursues Novel Neuropsychiatric Drug Class With Gilgamesh

Plus transactions involving Sanofi/Fulcrum, Reneo/OnKure, Lilly/Mitsubishi Tanabe, Lantern/Oregon, Zydus/Eiger and more.

Deal Watch Business Strategies

US FDA Rejects Onpattro Label Expansion: History Repeats In Reverse?

In going against an advisory committee vote, the agency produces ironic echoes with the history of the approved treatment for ATTR-CM, Pfizer’s Vyndaqel.

Advisory Committees Complete Response Letters

Alnylam’s Complete Response Is Classic Example Of FDA-Advisory Committee Disagreement

The situation also is a perfect example of FDA doing what it says it does – paying more attention to the thinking behind advisory committee votes than the votes and vote totals themselves.

Complete Response Letters Advisory Committees

Keeping Track: Return & Renewal At US FDA

Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.

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    • Silverback Therapeutics, Inc.
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