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Amylyx Pharmaceuticals, Inc : Amylyx Pharmaceuticals Announces EMA Validation of Marketing Authorisation Application (MAA) for AMX0035 for the Treatment of ALS

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) ("Amylyx" or the "Company"), today announced that its Marketing Authorisation Application (MAA) to the European Medicines Agency's (EMA) Committee for Medicinal

United statesTammy sarnelliBecky gohslerSeanm healeyLindsey allenAmylyx pharmaceuticals incGlobal head of regulatory affairs amylyxLeandrop rizzuto foundationExchange commissionTreatment research initiative to cureAmylyx pharmaceuticalsEuropean organization for professionalsEuropean medicines agencyCommittee for medicinal products human useMarketing authorisation applicationMedicinal products

Fixed-Dose Combo Therapy for Amyotrophic Lateral Sclerosis Gets Priority Review

The FDA has accepted for Priority Review the New Drug Application for AMX0035 (sodium phenylbutyrate and taurursodiol) for the treatment of ALS.

United statesTreatment research initiative to cureDrug administrationAccess programPriority reviewNew drug applicationMerit cudkowiczMassachusetts general hospitalJulieanne dorn professorHarvard medicalTreatment research initiativePrescription drug user fee act

Amylyx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application (NDA) for AMX0035 for the Treatment of ALS

Press release content from Business Wire. The AP news staff was not involved in its creation.

United statesUnited kingdomSpaulding rehabilitation hospitalTammy sarnelliBecky gohslerJustin kleeSeanm healeySabrina paganoniJoshua cohenAmylyx pharmaceuticals incGlobal head of regulatory affairs amylyxLeandrop rizzuto foundationDrug administrationHarvard medical schoolExchange commissionAmylyx pharmaceuticals

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