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NEWS

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…
August 27, 2026

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Abbott
NEWS

Abbott Secures FDA Authorization for Libre Duo 10 Day, a Dual Glucose-Ketone Sensing Technology

Shots: FDA has approved Libre Duo 10 Day, a dual glucose-ketone sensing biowearable, to provide real-time glucose monitoring while continuously detecting rising ketones for diabetic ketoacidosis (DKA) emergency, with launch expected later this year Libre Duo 10 Day met FDA standards for both integrated continuous glucose monitoring (iCGM) & the new integrated continuous glucose &…
August 26, 2026

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NEWS

BeOne Medicines Reports the US FDA Approval of Tevimbra + Ziihera to Treat HER2+ GEA

Shots: The US FDA has approved the sBLA for Tevimbra (tislelizumab) + Ziihera (zanidatamab) & CT for the 1L treatment of adults with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA)  Approval was based on the P-III (HERIZON-GEA-01) assessing the efficacy & safety of Ziihera+ CT, with and without Tevimbra, to the…
August 26, 2026

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BioCryst
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BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Shots: The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE) Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology BioCryst plans to launch…
August 26, 2026

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NEWS

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…
August 26, 2026

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Rhythm Pharmaceuticals
NEWS

Rhythm Pharmaceuticals’ Imcivree Secures MHLW Approval for Acquired Hypothalamic Obesity

Shots: The MHLW has approved Imcivree (setmelanotide) for pts (≥4yrs.) with acquired hypothalamic obesity (HO); commercial launch is expected by end of 2026, pending final pricing determination Approval was backed by the P-III (TRANSCEND) trial assessing Imcivree in 142 pts with acquired HO, incl. Japanese (n=12) & supplemental pts (n=10), which met its 1EP with…
August 25, 2026

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NEWS

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…
August 25, 2026

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