FDA sends Supernus Pharmaceuticals a second complete response letter on its NDA resubmission for the companys apomorphine infusion device (SPN-830) fo...
Federal Register notice: FDA requests nominations for voting members, excluding consumer and industry representatives, to serve on CDRHs Patient Engag...
Federal Register notice: FDA announces a 6/6 public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Bios...
Federal Register notice: FDA determines that 24 listed drug products were not withdrawn from sale for reasons of safety or effectiveness.
FDA grants Onkos Surgical a de novo marketing authorization for its novel antibacterial coated implants.
Federal Register notice: FDA issues an order to debar for five years Robert Lance Shuffert from importing or offering for import any drug into the U.S...
FDA approves a Bristol Myers Squibb and 2Seventy Bio supplemental BLA for Abecma (idecabtagene vicleucel; ide-cel) for treating certain adult patients...
Honeywell Safety Products recalls its Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station due to GMP concerns.
