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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
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
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
The FDA is preparing to conduct what it’s calling the first-ever systemic study examining how pharmaceutical brand names influence perceptions about drug efficacy. Read More
A federal judge has granted Eli Lilly’s request to halt an HHS final rule for its 340B drug discount program, siding with the drugmaker in finding that the department didn’t follow rulemaking requirements or give enough time for comment. Read More
A U.S. District Court has dismissed major accusations made in a high-stakes lawsuit brought by Minnesota Attorney General Keith Ellison alleging that three big drugmakers engaged in price gouging of diabetes drugs, thus violating the Racketeer Influenced and Corrupt Organizations (RICO) Act. Read More
In a revision of its Emergency Use Authorizations (EUAs) for Eli Lilly’s and Regeneron’s antibody combination therapies for COVID-19, the FDA is requiring the companies to assess the therapies against the mutant strains of the SARS-CoV-2 virus. Read More
The FDA has launched a new online dashboard for adverse event reporting of COVID-19 products that have received Emergency Use Authorizations (EUAs). Read More