Major drugmakers are participating in a new FDA fast-track review program despite concerns about potential legal risks. The ...

A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...

The FDA has delayed reviews of two drugs in the Trump administration's fast-track program due to safety concerns, including a ...

FDA delayed fast-track reviews for multiple drugs after safety and efficacy concerns, including adverse events and a reported ...

Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

The U.S. Food and Drug Administration (FDA) announced that it will fast-track review of nine experimental drugs. The move is part of a Trump administration program aimed at prioritizing medicines that ...

The US Food and Drug Administration (FDA) has granted Fast Track Designation to Complement Therapeutics’ CTx001, the ...

・Disc Medicine management said earlier this month that its application seeking approval for Bitopertin has officially been accepted for review on schedule. ・Wall Street analysts dismissed the media ...

DPTX3186 targets the Wnt/β-catenin pathway, crucial in gastric cancer, by forming drug-induced condensates to modulate β-catenin activity. Fast track designation accelerates development and review, ...

The FDA granted fast track status to VectorY’s VTx-002, an antibody gene therapy targeting TDP-43 protein aggregates in ALS.