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The first U.S. COVID-19 vaccinations are to be given today using Pfizer/BioNTech’s vaccine, following the announcement late Friday that the FDA had granted the first emergency clearance for a coronavirus vaccine, a pivotal and unprecedented moment in the battle against the pandemic. Read More
UX701 is currently in late preclinical development, and the company expects to file an Investigational New Drug application before the year ends. Read More
Even in the midst of the COVID-19 pandemic, not all vaccine news has to do with the coronavirus: Pfizer said this week that the FDA has accepted for priority review a biologics license application (BLA) the company filed for its vaccine against a form of streptococcus that can lead to fatal infections. Read More
Approval was supported by a phase 3 study enrolling 125 HAE patients, with attacks reduced by 87 percent vs. placebo when administered biweekly at a 300-mg dosage. Read More
The agency granted the designation based on initial data from patients enrolled in the phase 1 and 2 portions of its TRIDENT-1 study, the company says. Read More
Sinopharm, a state-owned Chinese drugmaker, has received full approval from the United Arab Emirates (UAE) for its inactivated COVID-19 vaccine, making the UAE the first nation outside China to grant such approval. Read More
The COVID-19 pandemic does not appear to be slowing down the rate at which the FDA is approving novel drugs, although there is anecdotal evidence that it is causing the agency to miss some deadlines for approvals under the Prescription Drug User Fee Act (PDUFA). Read More