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.
A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only way to successfully...
The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adopti...
FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus prevention product Beyfortu...
Novo Nordisk sues Lilly in New Jersey federal court over what the company says is a misleading national ad campaign that compares the two companies GL...
FDA warns Indias Shimoga Chemicals about CGMP deviations in its production of active pharmaceutical ingredients.
FDA warns Indias Alembic Research Center that it failed to obtain informed consent for an in vivo bioequivalence study.
