Drug Approval | February 23, 2023
Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
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
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
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
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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
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
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