Six former FDA commissioners – Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney and Andrew von Escehenbach – signed a joint letter urging the U.S. president to nominate a permanent commissioner soon.
The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
ReutersThe U.S. government on Feb. 27 authorized Johnson & Johnson’s single-dose Covid-19 vaccine, enabling millions more Americans to be vaccinated in the coming weeks and setting the vaccine up for additional approvals around the world.
Merck will have to wait to see if a Covid-19 therapeutic gained in November through the $425 million acquisition of OncoImmune can receive Emergency Use Authorization (EUA) after the U.S. Food and Drug Administration requested additional data beyond the Phase III study announced during 2020
The cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending Merck’s checkpoint inhibitor Keytruda (pembrolizumab) as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) to a combination of Eli Lilly and AbCellera’s monoclonal antibody bamlanivimab and the Lilly antibody etesevimab for mild to moderate Covid-19.
Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.
Eli Lilly and Co. will move a new Covid-19 antibody therapy to human trials targeting a coronavirus variant that was first found in South Africa, the U.S. drugmaker said.
GlaxoSmithKline discontinued a Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody aimed at treating ulcerative colitis licensed from Australia-based Immutep Limited following an interim assessment of an Independent Data Monitoring Committee.
