ARS Pharmaceuticals, Inc.
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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.
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.
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.
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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Pharmaceuticals
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Drug Delivery
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Drug Delivery
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- Silverback Therapeutics, Inc.
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