FDA
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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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.
With the accelerated approval from the U.S. Food and Drug Administration, Vijoice becomes the first treatment approved in the United States for PROS