This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
The company will engage with the agency to resolve the import alert at the earliest.
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
35 million mosquito nets supplied to countries in sub-Saharan Africa through partners
Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
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