Pfizer Announces The FDA Has Accepted The Company's Biologics License Application For Marstacimab; European Marketing Authorization Application For Marstacimab Has Also Passed Validation And Is Under Review By EMA
Portfolio Pulse from Benzinga Newsdesk
Pfizer has announced that the FDA has accepted its Biologics License Application for Marstacimab. Additionally, the European Marketing Authorization Application for Marstacimab has passed validation and is currently under review by the European Medicines Agency (EMA).
December 11, 2023 | 9:31 pm
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Pfizer's Marstacimab application has been accepted by the FDA and is under review by the EMA, indicating progress in the drug's regulatory approval process.
The acceptance of Pfizer's Biologics License Application for Marstacimab by the FDA and the validation of its application by the EMA are significant regulatory milestones. This news is likely to be viewed positively by investors as it suggests potential future revenue streams for Pfizer if the drug is approved. The impact on the stock price should be positive in the short term as it reflects progress in the company's pipeline.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100