FDA publishes a guidance with recommendations for select NDAs and BLAs submitted for Real-Time Oncology Review.
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.
