Drug Approval | February 25, 2023
Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
Acceptance based on results from the phase 3 KEYNOTE-091 trial
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