News
A selection of August 2026 news from pharmaceuticals, medical devices, clinical research services and healthcare.
Open Serbian versionOn 5 August, the FDA approved Takeda's Orzeyful (oveporexton) for adults with narcolepsy type 1. It is the first approved medicine to directly restore orexin signalling and address the disorder's full symptom range rather than individual manifestations.
Source: FDA
The FDA granted accelerated approval on 6 August to Tudriqev (vusolimogene oderparepvec-wtpg), used with nivolumab for adults with advanced cutaneous melanoma that progressed after PD-1-based treatment. Among 91 evaluated patients in the 140-patient trial cited by the agency, 24% responded and median response duration was 14.1 months. Continued approval is contingent on verification of clinical benefit in confirmatory trials.
Source: FDA
On 26 August, the FDA approved Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma after prior systemic therapy or when multiagent therapy is unsuitable. In the agency's account of a 500-patient randomized trial, median overall survival was 13.2 months versus 6.7 months with standard chemotherapy.
Source: FDA
Jazz Pharmaceuticals agreed on 10 August to acquire Actio Biosciences for $820 million upfront and up to $500 million in contingent consideration. The transaction adds ABS-1230, a clinical-stage KCNT1 inhibitor for genetically defined epilepsy.
Source: Jazz Pharmaceuticals
The FDA issued a discussion paper on 18 August seeking input on risk assessment, premarket evaluation and postmarket monitoring for generative-AI-enabled medical devices. The agency invited manufacturers, clinicians, researchers and the public to submit feedback by 19 October 2026.
Source: FDA
On 19 August, the FDA authorized Vitestro's Aletta through the De Novo pathway. The standalone robot locates a vein with near-infrared light and Doppler ultrasound and performs the blood draw under trained supervision; one phlebotomist may oversee up to three devices.
Source: FDA
The FDA authorized Abbott's Libre Duo 10 Day on 25 August for people aged two years and older with diabetes. It is the first US wearable to continuously monitor ketones and the first device globally to continuously track ketones and glucose together.
Source: FDA
McKesson announced on 25 August an agreement to acquire Precision Medicine Group. The group combines biomarker intelligence, laboratory services, a global CRO, market-access consulting and commercialization support.
Source: McKesson
On 20 August, the FDA published key considerations for developing and using digitally derived measures in clinical investigations. The paper draws on existing FDA guidance and discusses evidence supporting the selection, relevance and validity of these measures.
Source: FDA
CMS announced multiple late-August investments through the Rural Health Transformation Program, including $149.3 million for Arkansas, $122 million for Virginia and $93.3 million for Georgia. The announced uses include telehealth, remote monitoring, specialty access, infrastructure and surgical robotics.
Sources: CMS — Arkansas | CMS — Virginia | CMS — Georgia
