Four drug companies suggest changes to a proposed FDA study of multiple indications in DTC television ads.
FDA approves an Athena Bioscience NDA for Qdolo (tramadol hydrochloride) oral solution 5mg/1ml, an opioid agonist indicated in adults for managing pai...
Natco Pharma asks FDA to deny all relief sought in a petition by Taiho Oncology seeking protection of Lonsurf (trifluridine/tipiracil) from generic co...
FDA solicits feedback on desired features in a new medical device premarket submission tracker it is building.
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...