New Day Skin Spray uses a silk fibroin-containing barrier formulation and reached the US market through FDA’s 510(k) medical-device pathway rather than drug approval.
FDA Fast Track designation could increase regulatory interaction around safusidenib while Nuvation Bio tests the IDH1 inhibitor across several glioma settings.
FDA authorizes Vitestro’s Aletta robotic blood draw device via De Novo. See how its clinical data could reshape outpatient phlebotomy.
FDA grants LTI-03 Fast Track status as Rein advances its 120-patient Phase 2 IPF trial toward a closely watched second-half 2026 readout.
FDA clearance gives Maverix Medical a 2027 U.S. launch path for its console-free Narwhal Cryo System, but adoption will hinge on workflow and economics.
PleoPharma secures $6.5M NIDA funding as a 420-patient Phase 3 trial tests PP-01 for cannabis withdrawal in adults with cannabis use disorder.
ProCare Injury Specialists adds Waco as its 14th Texas clinic, extending its integrated accident-care network across Central Texas.
Guardian Pharmacy heads to Jefferies after raising 2026 guidance as IRA pricing masks stronger resident growth and margin gains.
Ingenia Therapeutics gains dual Prix Galien nominations as its KOSDAQ debut puts MK-8748, IGT-303 and the broader TIE2 pipeline under scrutiny.
Soft Bones urges South Korea to widen HPP reimbursement as age and radiographic criteria restrict treatment access for some patients.