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French medtech startup Naox Technologies this month became the first company to receive FDA 510(k) clearance for an in-ear electroencephalogram (EEG) device — a move that could shift brain monitoring away from bulky, scalp-based EEG systems to a compact ear-worn platform. Unlike traditional EEG systems that use upwards of 20 scalp electrodes, Naox’s device aims…
A Bayer drug that hits two central nervous system targets to treat moderate-to-severe menopause symptoms has FDA approval, introducing a new non-hormonal therapeutic option that may have an advantage over an Astellas Pharma product that has a two-year head start in this market. The Bayer drug, elinzanetant, is a small molecule formulated as a soft…
A subcutaneously injected version of Merck cancer immunotherapy Keytruda is now FDA approved, a regulatory decision that gives patients a less burdensome dosing option and provides the pharmaceutical giant a way to retain some market share as the original intravenously infused formulation — its top-selling product — faces patent expirations. The approval announced Friday covers…
