A Reuters article looks into drug GMP issues raised by FDA inspections over the past decade at Thermo Fisher's Greenville, NC drug contract manufactur...
FDA says the shortage of Lillys Mounjaro and Zepbound has been resolved but other similar products remain in short supply.
FDA lifts a partial clinical hold on Avidity Biosciences delpacibart etedesiran (del-desiran/AOC 1001) that is being evaluated for treating myotonic d...
FDA has released the form FDA-483 with five observations from an inspection at the Lakewood, CO-based BSO outsourcing facility.
FDA releases a list of 18 drug products for which there was a potential signal of serious risks or new safety information in the second quarter.
FDA grants Amphix Bio a breakthrough device designation for its drug-device combination product for bone regeneration.
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment of adults with resect...
FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Provells Euthyrox (levothyroxine sodium).
