FDA grants Pfizer COVID-19 vaccine priority review for full approval
Pfizer today said its COVID-19 vaccine will receive a priority review from the Food and Drug Administration, indicating that Pfizer has completed its rolling submission of its application for the vaccine’s full authorization. The company’s Biologics License Application, which is intended for individuals age 16 and older, is supported by clinical date from its phase 3 clinical trial.
Related News Articles
Headline
The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing…
Headline
The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of…
Headline
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled…
Headline
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…
Headline
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial…