Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
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
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
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%
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