AbbVie files a BLA seeking accelerated approval for Teliso-V (telisotuzumab vedotin) and its use in certain adult patients with previously treated non...
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.
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Three stakeholder organizations make comments and suggestions for changes in an FDA draft guidance on diversity action plans to increase representatio...
FDA lifts a clinical hold on Biomea Fusions Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in Type 2 and Type 1 dia...
