FDA approves a Merck BLA for Enflonsia (clesrovimab-cfor) for preventing respiratory syncytial virus lower respiratory tract disease in neonates and i...
Citing an inadequate clinical trial, FDA refuses to file an Axsome NDA for its fibromyalgia drug AXS-14 (esreboxetine).
Merck touts promising topline results from two Phase 3 clinical trials evaluating investigational enlicitide decanoate, an oral PCSK9 inhibitor for us...
A JAMA viewpoint article raises alarms about FDAs full approval last month of Novavaxs Covid-19 vaccine and the agencys unusual delay and politically ...
Amneal Pharmaceutical recalls three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their tablet surface due to ...
Arvinas files an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative ESR1-mu...
Baxter recalls its Novum IQ large volume pump after becoming aware of the potential for underinfusion following use of the devices standby mode featur...
A House Subcommittee markup votes along party lines to vote out and advance the agencys FY 2026 spending bill to the full committee.
