FDA approves an Iterum Therapeutics NDA for Orlynvah (sulopenem etzadroxil and probenecid) for treating certain uncomplicated urinary tract infections...
FDA grants Kind Pharmaceutical an orphan drug designation for AND017 and its use in treating sickle cell disease.
Smiths Medical recalls specific lots of its BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect.
PhRMA and USP recommend that FDA develop product class-specific guidances rather than product-specific guidances to spur the development of new biosim...
Federal Register notice: FDA announces a 12/4 Pharmacy Compounding Advisory Committee meeting to discuss various bulk drug substances being considered...
Intellia Therapeutics reports positive data from the ongoing Phase 1/2 study of NTLA-2002, a CRISPR-based gene editing therapy, in patients with hered...
The Public Citizen Health Research Group calls for a federal investigation into clinical trials for two Alzheimers drugs that may have violated inform...
Baxter Healthcare recalls (Class 1) its Life2000 ventilator to update the use instructions after finding that the device may fail to issue a low gas p...
