Approvals
The U.S.Food and Drug Administration has granted Emergency Use Authorization to a breathalyzer that can detect COVID-19 within three minutes.
Regeneron announced that the U.S. FDA has extended its review of the BLA for monoclonal antibody REGEN-COV, which treats COVID-19.
The FDA issued new guidance urging drugmakers to submit racial and minority recruitment plans when designing their studies.
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
AbbVie and Genmab announced positive topline results from their Phase I/II trial for lymphoma treatment; Sanofi posted positive results from its Phase I/II trial for the treatment of ITP.
Pfizer and BioNTech will submit updated data to the FDA to support the Emergency Use Authorization (EUA) of COVID-19 vaccination boosters in children between the age of 5 and 11.
Curis, a biotech company that develops treatments for cancer, has announced that the FDA has placed a partial clinical hold on its TakeAim lymphoma study.
The U.S. FDA greenlit China-based Triastek’s IND Application for its 3D printed drug product, T20, for cardiovascular and clotting disorders.
Alnylam Pharmaceuticals issued a proxy filing ahead of its May 18, 2022, Annual Meeting of Stockholders to inform stockholders of several items they can vote on at the end of the meeting.
The American Academy of Neurology Annual Meeting (AAN) was held virtually and in-person in Seattle from April 2-7. Here’s a look at some of the highlights.
PRESS RELEASES