Imbria Pharmaceuticals plans a Phase 3 study of ninerafaxstat, a novel cardiac mitotrope and partial fatty acid oxidation inhibitor, in patients with ...
Nurse Assist recalls 13 brands of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to the potential for a lack of sterilit...
Congresswoman Claudia Tenney (R-NY) introduces the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act.
FDA says a Covid-19 guidance on container closure systems is expected to be effective until 8/7/2024.
Johnson & Johnson says it will submit an IDE in the second half of 2024 to start trials of its Ottava surgical robot.
CDER researchers say 39% of breakthrough therapy designation requests between 2017 and 2019 were approved by FDA.
FDA clears a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes.
FDA grants Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast cancer with leptomening...
