The U.S. 9th Circuit Court of Appeals reverses an earlier California lower court decision that ruled a stem cell treatment firm is exempt from FDA reg...
An investigation by the journal Science questions the data behind a Parkinsons drug under development by Prothena and based on falsified research invo...
FDA grants Eli Lilly full approval for Retevmo (selpercatinib) for certain adult and pediatric patients two years of age and older with advanced or me...
AbbVie files a BLA seeking accelerated approval for Teliso-V (telisotuzumab vedotin) and its use in certain adult patients with previously treated non...
Four Ropes & Gray attorneys identify the key provisions in three new FDA clinical trial modernization guidances.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for SpringWorks Therapeutics Ogsiveo (nirogacestat ...
Pfizer withdraws its sickle cell disease drug Oxbryta from all approved markets after data show the overall benefit does not outweigh the risks.
Three stakeholder organizations make comments and suggestions for changes in an FDA draft guidance on diversity action plans to increase representatio...
