Coronavirus Update: Pfizer, BioNTech Hit Ground Running On Vaccine EUA
US FDA will hold 10 December advisory committee on Pfizer/BioNTech's just-filed application; the WHO issued a recommendation against Gilead's Veklury for hospitalized patients.
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Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study
US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.
Development of vaccines usually takes years, but drug makers whittled the process down to a matter of months amid a concerted response to a global health threat.
The European Medicines Agency will continue working over the Christmas period so that it can complete its assessment of the newly filed marketing applications for BioNTech/Pfizer’s and Moderna’s COVID-19 vaccines as soon possible.