EU CHMP Recommends AstraZeneca’s Wainzua for Rare Neuropathy Treatment
Key TakeawaysAstraZeneca’s Wainzua (eplontersen) recommended for EU approval for treating hereditary transthyretin-mediated amyloidosis (ATTRv-PN) with polyneuropathy.
NEURO-TTRansform trial shows Wainzua improves neuropathy impairment...
EMA Confirms Non-Renewal of Translarna for Duchenne Muscular Dystrophy
Key TakeawaysThe EMA has reaffirmed its decision not to renew the marketing authorisation for Translarna, citing insufficient evidence of its efficacy in Duchenne...
Medicare Negotiates Lower Prices for Top 10 Prescription Drugs Under Biden Administration
Key TakeawaysThe Biden Administration has successfully negotiated significant price reductions for the first ten drugs selected for Medicare price negotiations.
Reductions, including for...
Key TakeawaysRoche’s Evrysdi® (risdiplam) demonstrated that the majority of children with spinal muscular atrophy (SMA), treated pre-symptomatically before six weeks of age, were...
Key TakeawaysGermitec’s Chronos® device has achieved the first-ever FDA De Novo clearance for a UV-C High-Level Disinfection chamber, providing a chemical-free and automated...
Pharmaceutical Industry in Japan Faces Challenges Amid Reforms to Attract Global Drugmakers
Key TakeawaysJapan's pharmaceutical industry faces challenges due to stringent price controls and regulatory hurdles, leading to drug delays and reduced global competitiveness.
The...
Significant Healthcare Updates to Türkiye’s Health Implementation Communiqué by SGK
Key TakeawaysThe Turkish SGK has introduced significant amendments to the SUT, focusing on stricter guidelines for medication prescription to enhance patient-centered care and...
Cancer Treatment Recommendations Updated by Medicinrådet: New Approvals and Reevaluations Announced
Key TakeawaysMedicinrådet has approved five new treatment recommendations, including enfortumab vedotin for bladder cancer, citing its potential to extend patient survival despite higher...
Key TakeawaysMedicinrådet has expanded the recommendation for risdiplam, making it accessible to SMA patients of all ages, including those over 25, following a...
Myasthenia Gravis Treatment: Johnson & Johnson Seeks FDA Approval for Groundbreaking New Therapy
Key TakeawaysNipocalimab offers a promising new option for patients with generalized myasthenia gravis.
The treatment demonstrated superior outcomes in a diverse patient population.
...
Ultrasound Technology Achieves Milestone with FDA Clearance for AI-Powered POCUS Software Platform
Key TakeawaysAISAP's CARDIO software platform has received FDA clearance, making it the first globally approved for comprehensive diagnosis of structural heart diseases using...
