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Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) Receives the EC’s Conditional Approval for MASH with Liver Fibrosis
Shots: The EC has granted conditional approval to Rezdiffra to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to adv. liver fibrosis in 30 EEA states; launch is planned throughout EU starting with Germany in Q4’25 Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…
August 20, 20250Comments
Drug Discovery and Innovation Programme 2025
EVENTS
Drug Discovery and Innovation Programme 2025 | Sep 25-26 |Barcelona, Spain
A B2B event designed to connect Drug Discovery Experts, Biotech Innovation, and emerging technologies. This expert-led, two-day event blends keynotes, case studies, panel discussions, and 1:1 meetings to turn research into real-world impact. For any queries, reach out to Tina Aston at ta@worldbigroup.com Related Post: Clinical Trials Operations DACH 2025 | Sep 18 | Basel,…
August 20, 20250Comments
NEWS
ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury
Shots: ONWARD Medical has received the US FDA IDE approval to initiate its Empower BP study evaluating ARC-IM System for blood pressure instability in spinal cord injury The IDE trial will assess ARC-IM System in pts with C2–T6 spinal cord injuries, injury severities of AIS A-D & blood pressure instability, incl. chronic OH & autonomic…
August 19, 20250Comments
NEWS
RemeGen Enters a Licensing Agreement with Santen Pharmaceutical for RC28-E to Treat Eye Diseases
Shots: RemeGen has granted Santen exclusive rights to develop, manufacture, & commercialize RC28-E in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan), South Korea, Thailand, Vietnam, Singapore, Philippines, Indonesia, & Malaysia, while RemeGen will retain its rights in other territories As per the deal, RemeGen will receive $38.9M (¥250M) upfront, ~$72.3M (¥520M) in…
August 19, 20250Comments