FDA issues Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firm’s Orlando, FL manufacturing facility.
FDA approves a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), adding patients with dystrophic epidermolysis bullosa.
FDA issues Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firm’s Orlando, FL manufacturing facility.
FDA approves a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), adding patients with dystrophic epidermolysis bullosa.
FDA grants Merck and Daiichi Sankyo a breakthrough therapy designation for raludotatug deruxtecan and its use for treating patients with certain forms of platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers.
Dexcom recalls (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error.
