Samsung Electronics has received United States Food and Drug Administration (FDA) clearance for software that allows compatible Galaxy Buds to function as self-fitting, over-the-counter hearing aids for adults with perceived mild to moderate hearing impairment. The Hearing Aid Feature will initially be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the United States
Bristol Myers Squibb has secured accelerated approval from the United States Food and Drug Administration for Zenbexus, making iberdomide the first therapy from the company’s CELMoD class to reach the US market. The oral drug was approved as part of a three-drug regimen with subcutaneous daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma
FDA approves Lantheus’ Tauklarify for Alzheimer’s tau PET imaging. See what the scan detects, where errors arise and what could limit access.
FDA Fast Track gives spevatamig a faster regulatory path in biliary tract cancer as Phanes advances its Phase 2 and pembrolizumab strategy.
Aurisco’s FDA inspection for inclisiran sodium puts generic oligonucleotide manufacturing closer to a crucial regulatory and commercial test.
Fate Therapeutics has treated the first participant in RECLAIM-LN, a Phase 2 study evaluating its off-the-shelf CD19-directed CAR T-cell candidate FT819 in people with refractory moderate-to-severe lupus nephritis. The company disclosed the trial initiation on August 14, 2026, saying the first participant received FT819 in an outpatient setting and was discharged on the same day.
Rezatapopt completes key Phase 2 enrollment as PMV targets a Q1 2027 accelerated approval filing in TP53 Y220C ovarian cancer.
FDA approves TAUKLARIFY for tau PET imaging in Alzheimer’s evaluation. See how Lantheus’ new tracer fits into the evolving diagnostic market.
NVG-291 Phase 3 screening starts in September as NervGen targets hand-function recovery in chronic tetraplegia. See what RESTORE must prove.
FT819 enters a potentially registrational lupus nephritis trial with outpatient same-day dosing. See why Fate’s off-the-shelf CAR T model matters.