AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.
The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Clinical studies are expected to start in Q2 2023.
Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
Cipla has received 8 inspectional observations in Form 483
There is a fast resurgence in the transplant activities post COVID
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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
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