Latest Breaking News On - Conditional marketing authorization - Page 1 : comparemela.com

Last patient in: Laminar Pharmaceuticals S A completes recruitment for CLINGLIO, the phase 2b/3 Clinical Trial of idroxioleic acid (LAM561) in combination with RT and TMZ for adults with newly diagnosed glioblastoma

140 patients have been recruited at sites in Spain, Italy, France and United Kingdom.The open readout of the trial is expected by late 2024.Laminar aims to

United statesUnited kingdomPablo escribClinical operations at laminar pharmaceuticalsHealth solutionsLaminar pharmaceuticals saData monitoring committeeLaminar pharmaceuticalsEuropean commission grantClinical operationsConditional marketing authorizationIndependent data monitoring committeeMembrane lipid therapy

Travere Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

15.02.2024 - Received 459 new patient start forms (PSFs) for FILSPARI (sparsentan) in Q4 2023; Total of 1,452 PSFs received in 2023 Company nearing submission of sNDA to convert U.S. accelerated approval of FILSPARI in IgAN to full approval .

Deric dubeDrug administrationEuropean unionDevices agencyProgram updatesCommittee for medicinal products human useRenalys pharma incTravere therapeutics incExchange commissionContinuing operationsQuarter ended decemberNew drug applicationMedicinal productsHuman useConditional marketing authorizationRenalys pharma

CHMP Issues Negative Opinion for Renewal of Conditional Marketing Authorization for Translarnatm (ataluren) Following Re-examination Procedure

CHMP Issues Negative Opinion for Renewal of Conditional Marketing Authorization for Translarnatm (ataluren) Following Re-examination Procedure
lelezard.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from lelezard.com Daily Mail and Mail on Sunday newspapers.

United statesJeanine clementeKylie okeefeMatthewb kleinEuropean commissionTherapeutics incEuropean medicines agencyCommittee for medicinal products human useNegative opinionConditional marketing authorizationFollowing re examinationMedicinal productsHuman useDuchenne muscular dystrophyChief executive officerMore information

Travere Therapeutics Provides Corporate Update and 2024 Outlook

Received 459 new patient start forms for FILSPARI® in the fourth quarter of 2023; preliminary net product sales of FILSPARI totaled $15 million for the fourth quarter Company on track to submit.

Deric dubeExchange commissionEuropean unionProgram updatesCommittee for medicinal products human useTravere therapeutics incTravere therapeuticsNew drug applicationMedicinal productsHuman useConditional marketing authorizationKidney disease improving global outcomesClinical practice guidelineFocal segmental glomerulosclerosisImportant safety informationEndothelin receptor antagonists

Travere Therapeutics Reports Third Quarter 2023 Financial Results

Received 430 new patient start forms for FILSPARI® in the third quarter of 2023; demand and payer coverage continued to grow Net product sales of FILSPARI.

United statesNivi nehraDeric dubeNaomi eichenbaumMirum pharmaceuticalsAmerican society of nephrology kidney weekTravere therapeutics incCorporate communicationsEuropean unionProgram updatesDrug administrationCommittee for medicinal products human useExchange commissionMission pharmacal companyEuropean medicines agencyWeek late breakers