FDA grants Akamis Bio a fast-track designation to NG-350A for treating mismatch repair-proficient locally advanced rectal cancer.
Oncologist John Burke analyzes the positive and potentially negative impacts of FDAs new guidance on overall survival as an endpoint in oncology trial...
FDA approves a bioLytical Laboratories PMA for the INSTI HIV Self Test, an at-home HIV test that delivers results in 60 seconds or less.
FDA warns New York, NY-based Allovate Therapeutics that it is illegally marketing its Allerdent toothpaste that is an unapproved new drug.
FDA warns Nesconset, NY-based LifeVac that it is illegally marketing and distributing an airway clearance device.
FDA accepts for review a Cingulate NDA for CTx-1301 (dexmethylphenidate), a once-daily stimulant designed to treat attention-deficit/hyperactivity dis...
An Astellas Phase 2 study evaluating zolbetuximab in combination with standard chemotherapy for metastatic pancreatic cancer fails to meet its primary...
FDA publishes a guidance with recommendations for submitting clinical trial data sets for response assessments for treatments of acute leukemias.
