The FDA announced a shift away from animal testing for drug approval, citing advanced alternatives like AI and organoids ...

Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura ...

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal ...

The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...

The FDA granted a positive review for an acute myeloid leukemia drug trial, with initial dosing expected in 2025.

The Food and Drug Administration acted lawfully in rejecting PMTAs from 2 manufacturers of flavored liquids used in ...

End-to-end automation could offer significant benefits: speed, accuracy, and scalability. Digital workers perform repetitive ...

Researchers developed a manufacturing technique that rapidly generates large quantities of nanoparticles coated with drug-delivering polymers, which hold great potential for treating cancer. The ...

The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation ...

Conservative Leader Pierre Poilievre rolled out his strategy to tackle drug addiction Sunday, announcing a plan to fund ...

The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary ...