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Oncopeptides' Pepaxto Needs New Study To Identify Population That Will Benefit, FDA Panel Says
Pink Sheet
Advisory committee votes 14-2 that melflufen's benefit-risk profile is unfavorable in the current accelerated approval indication for fifth-line treatment...
1 month ago
Oncopeptides and Vector Pharma FZCO Announce Collaboration to Provide Pepaxti to Patients in the Middle East and ...
Yahoo Finance
DUBAI, United Arab Emirates and STOCKHOLM, Sweden, March 27, 2024 (GLOBE NEWSWIRE) -- Oncopeptides AB (STO: ONCO), a biotech company focused...
1 month ago
FDA Withdraws Approval of Melphalan Flufenamide for the Treatment of Multiple Myeloma
Pharmacy Times
The FDA announced a final decision to withdraw the approval of melphalan flufenamide (Pepaxto; Oncopeptides AB) combined with dexamethasone...
2 months ago
Cancer Drug Pepaxto Removed From US Market by FDA
Bloomberg
Oncopeptides AB's cancer drug Pepaxto will be pulled from the US market, the first example of regulators using new powers to rescind certain...
2 months ago
One trial, two regulators, two opinions on Oncopeptides drug
BioWorld MedTech
Supporting their conclusions with data from the same phase III study, the EMA's Committee for Medicinal Products for Human Use adopted a...
7 months ago
Melflufen Demonstrates Efficacy in LIGHTHOUSE Trial; Drug's Future Still Unclear
Cancer Therapy Advisor
Melflufen plus daratumumab and dexamethasone produced better outcomes than daratumumab alone in relapsed/refractory multiple myeloma.
8 months ago
Accelerated Approval: US FDA's Hammer Falls On Oncopeptides' Pepaxto
Pink Sheet
Rejecting company's appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify...
2 months ago
Oncopeptides and Vector Pharma collaborate on Pepaxti
The Pharma Letter
Swedish biotech Oncopeptides (Nasdaq Stockholm: ONCO) yesterday announced a collaboration with Vector Pharma FZCO to commercialize its...
1 month ago
FDA Tests New Power to Pull Some Fast-Tracked Drugs Off Market
Bloomberg.com
Its first target is a cancer treatment from Oncopeptides given accelerated approval in 2021, which has since faced a study questioning its...
7 months ago
Oncopeptides' Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures
Pink Sheet
Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal...
2 months ago