Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.
The CRL did not identify any outstanding scientific issues with the product.
Study achieves primary endpoint of radiographic progression-free survival
The reduction in force will result in financial savings of approximately $50 million annually beginning in 2023
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
Merck’s first microbiology application and training lab in India
The company was directed to submit a plan of compliance by July 15, 2022
The approval has been accorded by IFCI Limited for manufacturing of the product "7 ACA"
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