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...
Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consumer radio and TV ads w...
Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all that FDA and the me...
FDA approves GSK's Jideytro (zidesamtinib) for certain adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
