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
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
The new sterile filling line meets cGMP aseptic filling regulatory requirements
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
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Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI
Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated
The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product
The agreement between Eli Lilly and Janssen was established to allow the two companies to share resources for the goal of accelerating the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab).
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
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