Approvals
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.
With the accelerated approval from the U.S. Food and Drug Administration, Vijoice becomes the first treatment approved in the United States for PROS
The U.S. Food and Drug Administration (FDA) has approved BioXcel Therapeutics’ Igalmi, a drug designed to reduce agitation episodes in bipolar disorder and schizophrenia patients.
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the FDA’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture.
Kite Pharma, a subsidiary of Gilead, announced that its Yescarta® has been approved by the U.S. Food and Drug Administration (FDA).
PRESS RELEASES