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Cadrenal Granted FDA Fast Track Designation for Tecarfarin for Prevention of Blood Clots

Cadrenal Granted FDA Fast Track Designation for Tecarfarin for Prevention of Blood Clots
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Quang phamSean pokorneyDrug administrationDuke universityFast trackCadrenal therapeuticAccelerated approvalPriority reviewRolling reviewNew drug applicationOrphan drug designation

Sedana Medical receives FDA Fast Track Designation in the United States

/PRNewswire/ Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track.

United statesUnited kingdomGreat britainJohan spetzCertified adviser is erik penser bankDrug administrationFast track designationAccelerated approvalPriority reviewRolling reviewNew drug applicationJohannes dollSedana medicalRichmond agitation sedation scaleNasdaq first north growth marketCertified adviser

Immutep announces independent data monitoring committee positive recommendation to continue TACTI-003 trial as planned

Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the Independent Data Monitoring Committee (IDMC) for the randomised, controlled Phase IIb TACTI-003 trial has .

United statesNew south walesImmutep limitedDrug administrationData monitoring committeeCo incIndependent data monitoring committeeFast trackRolling reviewBiologic licenseAccelerated approvalPriority reviewMerck sharpEftilagimod alphaUnited states foodOverall response rate

Jazz (JAZZ) and Zymeworks (ZYME) Enter License Agreement to Develop and Commercialize Zanidatamab

Jazz (JAZZ) and Zymeworks (ZYME) Enter License Agreement to Develop and Commercialize Zanidatamab
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United statesKenneth galbraithZymework azymetricAsia pacificAndrean flynnRob iannoneCommission file noZymeworks incJazz pharmaceuticalsDrug administrationBeigene ltdInvestor relations jazz pharmaceuticalsExchange commissionZymeworks bc incCorporate communicationsEuropean medicines agency

Jazz Pharmaceuticals plc: Jazz Pharmaceuticals and Zymeworks Announce Exclusive License Agreement to Develop and Commercialize Zanidatamab, a HER2-Targeted Bispecific Antibody

Jazz to obtain exclusive development and commercialization rights in key markets including the U.S., Europe and Japan Zymeworks to receive $50 million upfront payment, a second payment

United statesBritish columbiaZymework azymetricKristin bhavnaniAndrean flynnDiana papoveKenneth galbraithAsia pacificRob iannoneJack spinksCommission file noZymeworks incJazz pharmaceuticalsDrug administrationBeigene ltdHead of global corporate communications