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FDA Issues Refusal to File Letter for Axsome’s Novel Fibromyalgia Candidate

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  • 2025-06-09 20:06 event
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FDA Issues Refusal to File Letter for Axsome’s Novel Fibromyalgia Candidate
FDA concluded that AXS-14’s New Drug Application was not sufficiently complete for substantive review, citing concerns with one of two clinical trials in fibromyalgia patients.

299. 5 Novels About the End of Democracy - CrimeReads

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5 Novels About the End of Democracy  CrimeReads

300. ‘Days of Light’ dramatizes life within the Bloomsbury Group - The Washington Post

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‘Days of Light’ dramatizes life within the Bloomsbury Group  The Washington Post

301. Une image de Taylor Swift dans « Wicked » générée par IA laisse les fans pris au dépourvu et en émoi.

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Les fans de Taylor Swift ont presque cru que la chanteuse ferait partie du casting de la suite de « Wicked ». La publication a été faite par un compte parodie sur X, l’ancien Twitter.

302. Anodyne Nanotech Drives Major Advancement in the Treatment of Sarcopenia with Novel Muscle-Preserving Therapy - BioSpace

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Anodyne Nanotech Drives Major Advancement in the Treatment of Sarcopenia with Novel Muscle-Preserving Therapy  BioSpace

303. Valérie Bah wins Amazon Canada First Novel Award - Quill and Quire

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Valérie Bah wins Amazon Canada First Novel Award  Quill and Quire

304. Un commentateur a enterré sa tête dans la poubelle après s’être senti dévasté au milieu de la dispute entre Trump et Musk.

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Scott Jennings, commentateur conservateur de CNN, enfouit sa tête dans une poubelle pour montrer comment lui et d'autres républicains se sentent après la dispute entre Donald Trump et Elon Musk.

305. Cranor on Long List for Twain American Voice Award - arkansastechnews.com

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Cranor on Long List for Twain American Voice Award  arkansastechnews.com

306. Novel Gene Risk Score Predicts Outcomes After RYGB Surgery - Medscape

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Novel Gene Risk Score Predicts Outcomes After RYGB Surgery  Medscape

307. Mosanna Therapeutics Launches with $80 Million to Advance Novel Nighttime Nasal Spray for Obstructive Sleep Apnea - PR Newswire

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Mosanna Therapeutics Launches with $80 Million to Advance Novel Nighttime Nasal Spray for Obstructive Sleep Apnea  PR Newswire

308. FDA Issues Refusal to File Letter for Axsome’s Novel Fibromyalgia Candidate

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FDA concluded that AXS-14’s New Drug Application was not sufficiently complete for substantive review, citing concerns with one of two clinical trials in fibromyalgia patients.

309. Traditional SAF Development Is Missing Benchmarks, A Novel Approach May Offer A New Route To Net Zero

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Traditional SAF Development Is Missing Benchmarks, A Novel Approach May Offer A New Route To Net Zero is part of our Air Transport World subscription.

310. 8 Sizzling Summer Romance Novels to Keep You Sweating All Season Long (Exclusive) - People.com

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8 Sizzling Summer Romance Novels to Keep You Sweating All Season Long (Exclusive)  People.com

311. Ukraine’s critical infrastructure subjected to novel PathWiper compromise - SC Media

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Ukraine’s critical infrastructure subjected to novel PathWiper compromise  SC Media

312. IceCure Receives Notice of Patent Allowance in U.S. for a Novel - GuruFocus

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IceCure Receives Notice of Patent Allowance in U.S. for a Novel  GuruFocus

313. Abbiamo letto “Brooklyn Crime Novel” di Jonathan Lethem (La Nave di Teseo): ma com’è? I ricchi rubano ai poveri anche nel XXI secolo e si racconta così: perché in Italia non sappiamo farlo? - Mowmag.com

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Abbiamo letto “Brooklyn Crime Novel” di Jonathan Lethem (La Nave di Teseo): ma com’è? I ricchi rubano ai poveri anche nel XXI secolo e si racconta così: perché in Italia non sappiamo farlo?  Mowmag.com

314. IceCure Receives Notice of Patent Allowance in U.S. for a Novel Cryogen Flow Control to Optimize Patient Outcomes - PR Newswire

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IceCure Receives Notice of Patent Allowance in U.S. for a Novel Cryogen Flow Control to Optimize Patient Outcomes  PR Newswire

315. Tiga Buku Hit di Indonesia yang Layak di Baca - Katakini.com

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Tiga Buku Hit di Indonesia yang Layak di Baca  Katakini.com

316. Baltimore’s July 4 fireworks will feature novel drone show, mayor says

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During a news conference Monday, Baltimore Mayor Brandon Scott said this year’s Independence Day fireworks display will include a drone show for the first time.

317. Canal Viva vira Globoplay Novelas nesta segunda-feira

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A partir desta segunda-feira, 9, às 20 horas, o Canal Viva passa a se chamar Globoplay Novelas, com programação dedicada inteiramente à teledramaturgia. O canal estará disponível nos mesmos pacotes de ...

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