In July 2024, Checkpoint announced that the FDA accepted for review the resubmission of its BLA for cosibelimab as a complete response to the complete response letter (“CRL”) issued in December 2023 ...
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, ...
Autolus Therapeutics ( (AUTL) ) has provided an announcement. Autolus Therapeutics has achieved a pivotal milestone with the FDA’s ...
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.
With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging ...
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Upon FDA approval of acoramidis, it is our intent to honor the courage ... which can be applied to another therapy in the ...
The law firm of Kirby McInerney LLP reminds investors that a class action lawsuit has been filed in the U.S. District Court for the District of Maryland on behalf of those who acquired Elanco Animal ...
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