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AstraZeneca’s (AZ) COVID-19 vaccine clocked in at 79 percent efficacy in preventing symptomatic infection and fully shielded against severe disease and hospitalization in the company’s phase 3 U.S. trial, opening the door for an Emergency Use Authorization (EUA) filing with the FDA in a matter of weeks. Read More
The Russian Direct Investment Fund (RDIF) and Indian contract manufacturer Stelis Biopharma have partnered to produce 200 million doses of the Sputnik V COVID-19 vaccine. Read More
HHS is postponing implementation of a final rule issued late in the Trump administration that would have required the FDA to review practically every regulation it has and redirect resources away from pandemic relief efforts. Read More
The FDA’s Office or Regulatory Programs has sent letters to 25 manufacturers, distributors and sellers telling them to stop producing and issuing these certificates. Read More
In a marked change in policy, the U.S. will send an estimated 4 million doses of AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine to Canada and Mexico, according to a White House press briefing yesterday. Read More
Top U.S. health officials, including an FDA regulator testified on Capitol Hill this week that real-world evidence from people vaccinated against COVID-19 and data from ongoing trials will be used to decide how vaccines should be updated to handle variant strains. Read More
The European Medicines Agency (EMA) has concluded its evaluation of a small number of blood-clot cases in patients vaccinated with AstraZeneca’s (AZ) COVID-19 vaccine, finding the two-shot inoculation is still safe and effective, though it could be associated with low levels of blood platelets in very rare instances. Read More
Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office approved 53 novel drugs, published 31 new guidances and wrapped up the reorganization it had been working on since 2019, said Peter Stein, OND’s director, in the office’s annual report. Read More
With the agency’s first full approval for a COVID-19 diagnostic, tests of the same type may now go through its 510(k) pathway for potential clearance. Read More