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SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDA

FDA Extending PDUFA Date by Three Months to Allow More Time to Complete Their Review; New PDUFA Date Set to November 27, 2023STAMFORD, Conn., June 05, 2023 SpringWorks Therapeutics, Inc. , a. | June 5, 2023

United statesSamantha hilson sandlerSaqib islamBone sarcoma groupEuropean medicines agencyDesmoid working groupSpringworks therapeutics incDesmoid tumor working groupEuropean organization for researchDrug administrationEuropean commissionEuropean consensus initiativeThree monthsAllow more timeComplete their reviewWorks therapeutics

SpringWorks Therapeutics Inc (SWTX) Announces PDUFA Date Extension for Nirogacestat NDA

SpringWorks Therapeutics Inc (SWTX) Announces PDUFA Date Extension for Nirogacestat NDA
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United statesSamantha hilson sandlerSaqib islamDesmoid working groupDesmoid tumor working groupBone sarcoma groupEuropean medicines agencyEuropean organization for researchEuropean commissionEuropean consensus initiativeSpringworks therapeutics incDrug administrationWorks therapeuticsPrescription drug user fee actNew drug applicationMajor amendment

BioMarin Announces Record Breaking First Quarter 2023 Results, Including 15% Year-over-year Growth of Total Revenues

Growth of VOXZOGO® Accelerated with Rapid Uptake in Japan and Brazil Resulting in Increased Full-year 2023 GuidanceFull-year 2023 Top-line and Bot.

United statesTraci mccartyJean jacques bienaimMarni kottleNational association of statuary health insurance fundsInternational numberCompany asCompany annualBiomarin genzymePrnewswire biomarin pharmaceutical incEuropean commissionExchange commissionDrug administrationBiomarin pharmaceutical incReplay international numberDevelopment expense

BioMarin Provides Update on FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) Gene Therapy for Adults with Severe Hemophilia A

/PRNewswire/ BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today.

Hank fuchsMarni kottleTraci mccartyDevelopment of biomarinEuropean commissionDrug administrationBiomarin pharmaceutical incExchange commissionWorldwide researchPrnewswire biomarin pharmaceutical incEuropean medicines agencyRobust clinical programTarget action dateMarin pharmaceuticalBiologics license applicationMajor amendment

Manipur doctors to go ahead with OPD shutdown protest

The All Manipur Health Services Doctors’ Association (AMHSDA) on January 5 announced shutdown of OPD services in all the government hospitals from January 9 followed by indefinite shutdown in connection with its demands.

Uttar pradeshNarendra modiManipur health services doctor associationPublic healthHealth family welfare servicesCommittee onCentral pay commissionByifp bureauAll manipur health services doctor associationFamily welfare servicesPrime minister narendra modiPrime ministerMajor amendmentMedical educationAnipur doctorsDoctors strike