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BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents

BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents 1 (Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU. The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) and plan to request additional amendments with other regulatory authorities worldwide.

United statesUnited kingdomSylke maasAndy widgerChuck trianoFosun pharmaEuropean commissionDrug administrationBayer animal healthExchange commissionEuropean unionEuropean medicines agencyRoche groupConditional marketing authorizationEmergency use authorizationMarketing authorization holder

Karyopharm Announces European Medicines Agency s Validation of its Type II Variation Marketing Authorization Application for NEXPOVIO®

Published: Apr 26, 2021 NEWTON, Mass., April 26, 2021 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Medicines Agency (EMA) has validated the Company s Type II Variation Marketing Authorization Application (MAA), which seeks to expand the currently authorized indication for NEXPOVIO® in the European Union to include, in combination with Velcade® (bortezomib) and low-dose dexamethasone, the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Validation of the application confirms the submission is complete to begin the EMA s review process. The MAA is supported by the positive results from the pivotal Phase 3 BOSTON study, which evaluated once-weekly selinexor in combination with once-weekly Velcade® and low-dose dexamethasone (SVd) compared to standard twice-weekly Velcade® plus low-dose dexamethasone

United statesSharon shachamSelective inhibitor of nuclear exportKaryopharm therapeutics incWorld health organizationEuropean commissionDrug administrationTakeda pharmaceutical companyCompany type ii variation marketing authorization applicationPrnewswire karyopharm therapeutics incExchange commissionEuropean unionKaryopharm selective inhibitor of nuclear exportEuropean medicines agencyCommittee for medicinal products human useMarketing authorization application

European Commission Approves JEMPERLI (dostarlimab), the First Anti-PD-1 Therapy Approved for Recurrent or Advanced dMMR/MSI-H Endometrial Cancer in Europe

European Commission Approves JEMPERLI (dostarlimab), the First Anti-PD-1 Therapy Approved for Recurrent or Advanced dMMR/MSI-H Endometrial Cancer in Europe
globenewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from globenewswire.com Daily Mail and Mail on Sunday newspapers.

United statesDennis mulroyHamza suriaBristol myers squibbAnaptysbio incEuropean commissionDrug administrationTesaro incExchange commissionClinical developmentAntibody under clinical developmentSolid tumorsAnaptysbio generated antibodyUnder clinical developmentObtain regulatory approvalPayment earned

Galapagos NV: Gilead Sciences submits new drug application in Japan for filgotinib for the treatment of ulcerative colitis with an inadequate response to conventional therapies

Galapagos NV: Gilead Sciences submits new drug application in Japan for filgotinib for the treatment of ulcerative colitis with an inadequate response to conventional therapies
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

Region flamandeUnited kingdomJapan generalGreat britainVan gijselElizabeth goodwinCarmen vroonenAnna gibbinsGilead scienceskkGilead sciencesMinistry of healthTherapeutic areas communicationsEisai co ltdJapanese ministry of healthGlobal head of communications public affairsDevices agency

AbbVie (ABBV) Receives Positive CHMP Opinion for VENCLYXTO® (venetoclax) | FinancialContent Business Page

April 23, 2021 at 08:49 AM EDT AbbVie Receives Positive CHMP Opinion for VENCLYXTOÂ® (venetoclax) as a Combination Regimen for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy AbbVie (NYSE: ABBV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for VENCLYXTOÂ® (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision on VENCLYXTO combination therapy for use in AML in the first half of 2021.

United statesRheinland pfalzCarmo almeidaMohamed zakiNational cancer instituteClinical trial programEuropean unionAbbvie deutschland gmbh coDepartment of hematologyCommittee for medicinal products human useAmerican cancer societyEuropean commissionInfectious diseases at university hospital in ulmExchange commissionEuropean medicines agencyRoche group