FDA releases its latest batch of Warning Letters that includes PT MegaSurya Mas and Calvin Scott and Co.
FDA cautions that a clinical study shows that Genentechs Tecentriq in combination with paclitaxel is not effective in treating mTNBC breast cancer.
FDA approves a Genentech NDA for Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection fusion-positive non-small ce...
An AstraZeneca and University of Oxford Phase 3 vaccine study stalls as a clinical hold is issued due to a serious adverse reaction in a trial partici...
Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetics in Patients with Impaired Renal Function Study Design, Data A...
Federal Register notice: FDA sends to OMB an information collection extension for Electronic Submission Process for Voluntary Allegations to the Cente...
Federal Register notice: FDA announces a 10/8 joint advisory committee meeting to review an Arbor Pharmaceuticals NDA for a drug to treat attention de...
Federal Register notice: FDA issues Nippon Shinyaku a priority review voucher after approval of its rare disease drug Viltepso (viltolarsen), indicate...