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
Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization
Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma
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
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population
Imfinzi also recommended for patients with mismatch repair deficient disease
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
Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months
Subscribe To Our Newsletter & Stay Updated
