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Three stakeholder organizations make comments and suggestions for changes in an FDA draft guidance on diversity action plans to increase representatio...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...
Investigative journalists write in BMJ about FDA advisory committee members financial conflicts of interest in the consideration of Lillys Kisunla whi...
Bayer submits a supplemental NDA for oral androgen receptor inhibitor Nubeqa (darolutamide), seeking approval for its use in combination with androgen...
The FDA Oncology Drugs Advisory Committee votes not to recommend using immune checkpoint inhibitors in first-line advanced gastric cancer with PD-L1 e...
