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Latest From ARS Pharmaceuticals, Inc.
First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval
The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.
US Rejected Drug Odronextamab Among 11 EU Marketing Hopefuls
Regeneron, whose blood cancer treatment odronextamab was recently turned down by the US regulator but not for reasons relating to efficacy or safety, could soon learn whether its product will be among the drugs to get the thumbs up from the CHMP, the European Medicines Agency’s human medicines committee.
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.
Company Information
- Industry
- Pharmaceuticals
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Pharmaceuticals
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Drug Delivery
- Nasal
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Drug Delivery
- Other Names / Subsidiaries
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- Silverback Therapeutics, Inc.
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