USA – FDA drafts data standards guidance for RWD
The US Food and Drug Administration (FDA) has released draft guidance for industry that outlines the agency’s thinking on how a sponsor should submit...
USA – Moderna COVID-19 vaccine generates long-lasting immune memory
The Moderna and Pfizer mRNA vaccines against COVID-19 have shown greater than 90% effectiveness soon after the second dose. Studies suggest that protective immunity...
USA – FDA okays Moderna, J&J, ‘mix and match’ boosters
The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines...
USA – The FDA vaccine advisory board recommends booster shots of both the J&J...
While the FDA usually follows the advice of its advisory committee, a final decision cannot be made until the vaccine advisory group of the...
USA – FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017,...
USA – FDA adcomm unanimous on J&J boosters for all
The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend a full-strength booster dose of the COVID-19...
USA – Unanimous thumbs up from FDA committee for Moderna booster
An advisory committee to the US Food and Drug Administration (FDA) voted unanimously to recommend a half-strength booster dose of the mRNA COVID-19 developed...
USA – New USP chapter details lifecycle approach to analytical testing
The United States Pharmacopoeia (USP) has released a new chapter 1220 ahead of publication in the USP-NF that sets a lifecycle approach to analytical method development with the...
USA – FDA’s accelerated approval program: Is change on the way?
The U.S. Food and Drug Administration (FDA) launched its accelerated approval program in 1992, offering a pathway to bring life-saving drugs and biologics to...
USA – FDA recognizes Memorial Sloan Kettering tumor variant database
The first somatic human variant database has been recognized by the US Food and Drug Administration for inclusion in its Public Human Genetic Variant...
