Drug Approval | December 14, 2024
Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy
Final decision from the European Commission is anticipated within the coming months
Final decision from the European Commission is anticipated within the coming months
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
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
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