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
For people with relapsed or refractory diffuse large B-cell lymphoma
The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
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
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype
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
The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)
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