FDA issues a Complete Response Letter to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combi...
FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotecti...
FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL.
FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated development, completing...
Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to improve population heal...
The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by eliminating require...
A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involving bioanalytical me...
Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqy...
