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Labcorp to offer FDA-cleared pTau-217 blood test for Alzheimer's assessment
24 August 2026 - US laboratory services company Labcorp Holdings, Inc. (NYSE: LH) announced on Monday that, following US Food and Drug Administration clearance, it will offer the Elecsys pTau-217 test nationwide.Developed by Roche Diagnostics, the bl...
Tempus announces receipt of FDA clearance for AI pulmonary hypertension detection product
24 August 2026 - Medical technology company Tempus AI Inc (NASDAQ: TEM) reported on Monday that it has received 510(k) clearance from the U.S. Food and Drug Administration for Tempus ECG-PH, an AI-enabled software device designed to analyse standard ...
European Commission grants orphan designation for Vanda's imsidolimab
24 August 2026 - US biopharmaceutical company Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), said on Monday it has received European Commission orphan designation for imsidolimab, its investigational monoclonal antibody for Generalised Pustular Psoriasis...
United Therapeutics wins FDA acceptance for ralinepag PAH filing
24 August 2026 - Biotechnology company United Therapeutics Corporation (Nasdaq:UTHR) said on Monday that the US Food and Drug Administration (FDA) has accepted its New Drug Application for ralinepag to treat pulmonary arterial hypertension (PAH), set...
Takeda wins Japan approval for ORZEYFUL to treat underlying cause of narcolepsy type 1
24 August 2026 - Japanese pharmaceutical company Takeda (TSE:4502) (NYSE:TAK) announced on Monday that Japan's Ministry of Health, Labour and Welfare has approved ORZEYFUL (oveporexton) for adults with narcolepsy type 1 (NT1, narcolepsy with cat...