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.
Pfizer says its Tukysa met the progression-free survival endpoint in the HER2CLIMB-05 breast cancer trial combining Tukysa with standard of care in ce...
FDA accepts for review a Rocket Pharmaceuticals BLA resubmission for Kresladi (marnetegragene autotemcel), a gene therapy for severe Leukocyte Adhesio...
