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Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy
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United statesUnited kingdomSwitzerland generalEva kaliasEzio magnanoReveragen biopharmaDario eklundMaggiec walterCatalyst pharmaceuticalsHead investor relations communicationsSanthera pharmaceuticalsAmerica to catalyst pharmaceuticalsCommittee for medicinal products human useEuropean medicines agencyEuropean commissionRegulatory agency

Takeda (TSE:4502) (NYSE:TAK) today announced the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of lanadelumab (trade name TAKHZYRO®) …

United kingdomUnited statesDidier relinFreeha rafiqHead of international regulatory at takedaCommittee for medicinal products human useTakeda pharmaceutical companyTakeda pharmaceutical company limitedEuropean medicines agencyEuropean commissionTakeda receives positiveRecommending approvalRoutine preventionRecurrent attacksHereditary angioedemaPatients aged

GasLog Partners LP : Report Of Foreign Private Issuer

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Exchange commission onSecurities exchangeExchange commissionNew york stock exchangeGaslog ltdPartnership annual report on formYork stock exchangeRevenue service formRecommendation of the conflicts committeePartnership boardGaslog partnersSpecial distributionAnticipated record dateInformation aboutAnticipated payment dateDue bill period

Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion Recommending Approval for Opdivo with Chemotherapy

Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion Recommending Approval for Opdivo with Chemotherapy
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South koreaUnited statesBristol myers squibbAbderrahim oukessouCommittee for medicinal products human useOno pharmaceutical coExchange commissionEuropean lung cancer congressEuropean commissionEuropean medicines agencyEuropean unionCompany opdivoRecommending approvalNeoadjuvant treatmentResectable non small cell lung cancerHigh risk

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expre

Recommendation based on results from the Phase 3 CheckMate -816 trial, in which Opdivo with chemotherapy demonstrated improved event-free survival and pathologic complete response compared to. | May 26, 2023

South koreaUnited statesBristol myers squibbAbderrahim oukessouCommittee for medicinal products human useOno pharmaceutical coEuropean commissionEuropean lung cancer congressEuropean medicines agencyEuropean unionCompany opdivoBristol myers squibb receives positiveRecommending approvalNeoadjuvant treatmentResectable non small cell lung cancerHigh risk