Drug Approval | September 23, 2024
Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA
Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma
PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration
Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission
Winrevair is the first activin signaling inhibitor therapy for PAH approved in Europe
PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration
Decision on EU marketing authorisation for this population expected by September 2024
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
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