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Revolution Medicines Reports the US FDA Approval of Rasonque (Daraxonrasib) for Previously Treated Metastatic PDAC
Shots: FDA has approved Revolution’s Rasonque to treat pts with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received ≥1 prior systemic therapy or who are not candidates for multiagent systemic therapy Approval was backed by P-III (RASolute 302) trial assessing Rasonque (300mg, QD, PO) vs CT, in the above-mentioned pts, regardless of RAS mutation, which met…
Haisco Licenses Preclinical Immunology Drug to Sentivera in $1.5B+ Deal
Shots: Haisco has entered into an exclusive licensing agreement with Sentivera to develop, manufacture, & commercialize one of its preclinical immunology assets globally, excl. Greater China, in a deal valued at more than $1.5 billion. The agreement incl. $75.89M in upfront payment & equity consideration, ~$1.46B in development, regulatory & commercial milestones, plus tiered royalties…
Tempus AI Secures FDA Clearance for AI-Enabled Pulmonary Hypertension ECG Tool
Shots: Tempus AI has received FDA 510(k) clearance for Tempus ECG-PH, an AI-enabled software device that analyzes standard 12-lead ECGs for signs associated with pulmonary hypertension (PH) Designed for patients aged 40 and older with cardiovascular symptoms but no known PH history, Tempus ECG-PH identifies ECG patterns associated with elevated mean pulmonary artery pressure Tempus…