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FDA Confirms Decision to Withdraw Melphalan Flufenamide Approval in Multiple Myeloma

The FDA has determined that sufficient criteria have been met to withdraw the approval for melphalan flufenamide in patients with multiple myeloma.

New yorkUnited statesJoshua richterFredrik schjesvoldPeter marksOncopeptide pepaxtiTisch cancer instituteEuropean commissionChelsea medical center at mount sinaiDivision of hematologyDrug administrationOncologic drugs advisory committeeEuropean unionBiologics evaluationFederal registerOrange book

Oncopeptides AB: Oncopeptides provides update on Pepaxto US marketing authorization

STOCKHOLM, Dec. 7, 2022 /PRNewswire/ Oncopeptides AB (publ) (NASDAQ Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological

United kingdomRolf gulliksenJakob lindbergEuropean unionDrug administrationEuropean medicines agencyGlobal head of corporate communicationsHealthcare products regulatory agencyKiller engagersGlobal headCorporate communicationsPeptide drug candidateMarketing authorizationMid capNasdaq stockholm

Oncopeptides AB: Briefing Book for ODAC meeting on benefit/risk profile of Pepaxto now published

STOCKHOLM, Sept. 20, 2022 /PRNewswire/ Oncopeptides AB (publ) (NASDAQ: ONCO) (Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological

Rolf gulliksenKlaas bakkerJakob lindbergEuropean unionEuropean commissionDrug administrationGlobal head of corporate communicationsBriefing bookOncologic drugs advisory committeeExecutive vice presidentChief medicalGlobal headCorporate communicationsEuropean economic areaMid capNasdaq stockholm

Oncopeptides AB: Oncopeptides rescinds voluntary withdrawal of Pepaxto in the US - no intent to market in the US at this time

STOCKHOLM, Jan. 21, 2022 /PRNewswire/ Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological

United kingdomRolf gulliksenKlaas bakkerLinda holmstrJakob lindbergDrug administrationGlobal head of corporate communicationsNasdaq stockholmOverall survivalGlobal headCorporate communicationsInvestor relationsCorporate headquartersMid cap

Oncopeptides AB: Oncopeptides withdraws Pepaxto in US, scale down organization and focus on R&D

STOCKHOLM, Oct. 22, 2021 /PRNewswire/ Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological

United statesUnited kingdomMartyj duvallRolf gulliksenKlaas bakkerLinda holmstrJakob lindbergDrug administrationEuropean medicines agencyGlobal head of corporate communicationsNasdaq stockholmPeptide drug conjugateConditional marketing authorizationChief executive officerGlobal headCorporate communications

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