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ALS Drug Gets FDA Panel Thumbs Up After Rare Second Look

An FDA advisory panel reversed its March decision to reject a novel drug for ALS, citing persuasive new evidence and clinician support.

United statesTammy sarnelliJustin kleeTeresa buracchioEmily freilichCaleb alexanderBilly dunnRegulatory affairs for amylyx pharmaceuticalsAmylyx pharmaceuticals incIndiana university school of medicineCentral nervous system drugs advisory committeeDrug associationOffice of neuroscienceAmylyx pharmaceuticalsDivision of neurologyMedscape medical news

No Benefit to Early Tracheostomy in Severe Stroke

The findings don t end debate on whether an early or standard approach to tracheostomy yields better outcomes, but does give clinicians a choice.

United statesBaden wübergUnited kingdomCity ofAlvaro moreiraJoanna wardlawUniversity of texas health san antonioDivision of neonatologyBoehringer ingelheimHeidelberg university hospitalUniversity of edinburghJournal of the american medical associationPlanning groupEuropean stroke organisation conferenceGerman society of neurologicalOutcomes research institute

FDA Advisory Panel Rejects Novel ALS Drug

A US Food and Drug Administration advisory committee is unconvinced by that a new drug for amyotrophic lateral sclerosis is effective.

United statesJamie timmonsJoshua cohenCaleb alexanderKenneth fischbeckAmylyx pharmaceuticalsAmylyx pharmaceuticals incNational institutes of healthCentral nervous system drugs advisory committeeJohns hopkins bloomberg school of public healthDrug associationNational institute of neurological disordersDistinguished investigatorNational instituteNeurological disordersNational institutes

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