[ Price : $8.95]
FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated dev...[ Price : $8.95]
Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to imp...[ Price : $8.95]
The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by...[ Price : $8.95]
A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involv...[ Price : $8.95]
Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecva...[ Price : $8.95]
Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consume...[ Price : $8.95]
Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all...[ Price : $8.95]
FDA approves GSK's Jideytro (zidesamtinib) for certain adults with locally advanced or metastatic ROS1-positive non-small cell lun...