FDA clears a Cianna Medical 510(k) to broaden the indication of its SCOUT reflector for use in localization of soft tissue.
FDA issues Pain Therapeutics a complete response letter for Remoxy, an abuse-deterrent, extended-release form of oxycodone.
Federal Register notice: FDA announces an 11/5 public hearing on the future format of the National Drug Code.
FDA posts a draft guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.
Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.
FDA grants Alteogen an orphan drug designation for ALT-P7 and its use in treating gastric cancer.
FDA clears a Strata Skin Sciences 510(k) for its Multi-Micro Dose tip accessory for its proprietary Xtrac 308nm excimer laser.
FDA grants Nohla Therapeutics a fast track designation for dilanubicel (NLA101) for patients with high-risk hematologic malignancies receiving an allo...