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Cytokinetics (CYTK) Receives CRL from FDA for Omecamtiv Mecarbil

Cytokinetics (CYTK) Receives CRL from FDA for Omecamtiv Mecarbil
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United statesRuoxiang jiangSusana westonShannonm dunlayMargaretm redfieldOmecamtiv mecarbilCytokinetics diane weiserseniorRoberti blumCytokinetics incorporatedHeart failure associationDrug administrationExchange commissionCytokinetics incorporated nasdaqCorporate communicationsEuropean society of cardiologyA report from the american heart association

Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil

Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil
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United statesRuoxiang jiangSusana westonShannonm dunlayMargaretm redfieldOmecamtiv mecarbilCytokinetics diane weiserseniorRoberti blumCytokinetics incorporatedAmerican heart associationHeart failure associationCompany expects to request meetingDrug administrationExchange commissionCytokinetics incorporated nasdaqCorporate communications

Cytokinetics Receives Complete Response Letter From FDA for

Complete Response Letter States that GALACTIC-HF Alone Does not Establish Substantial Evidence of Effectiveness Sufficient for Approval Company Expects to.

United statesRuoxiang jiangSusana westonShannonm dunlayMargaretm redfieldOmecamtiv mecarbilDiane weiserRoberti blumAmerican heart associationHeart failure associationCompany expects to request meetingDrug administrationExchange commissionCytokinetics incorporated nasdaqCorporate communicationsEuropean society of cardiology

Sage Therapeutics and Biogen Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression

Sage Therapeutics and Biogen Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
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United statesUnited kingdomKathryn ritzingerCharles weissmannWalter gilbertHeinz schallerLaura gaultPriya singhalMike henckeJack coxHelen rubinsteinKenneth murrayHead of researchCommittee opinion noDrug administrationRegulatory sciences at biogen

Jazz Pharmaceuticals plc: Jazz Pharmaceuticals and Zymeworks Announce Jazz has Confirmed Opt-in and Advances Partnership for Zanidatamab

Follows positive top-line clinical data readout from HERIZON-BTC-01 pivotal trial in biliary tract cancers DUBLIN and VANCOUVER, BC, Dec. 21, 2022 /PRNewswire/ Jazz Pharmaceuticals plc

United statesBritish columbiaZymelink auristatinWilson sonsini goodrich rosatiZymework azymetricKristin bhavnaniAndrean flynnDiana papoveKenneth galbraithAsia pacificRob iannoneJack spinksCommission file noJazz pharmaceuticals ireland limitedZymeworks incHealth partners