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...
CDRH posts four dental final guidances under its Performance Criteria for Safety and Performance Based Pathway program.
AbbVie says a pivotal Phase 3 (TEMPO-1) trial for tavapadon in early Parkinsons disease met its primary and secondary endpoints.
Federal Register notice: FDA proposes to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative and quantitative HBV antibody assa...
Four Ropes & Gray attorneys identify the key provisions in three new FDA clinical trial modernization guidances.
