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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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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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GSK
NEWS

GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W…
August 25, 2026

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NEWS

ivWatch Seeks 510(k) Clearance for its SmartTouch+ Sensor to Expand Continuous IV Monitoring to White-Opaque Infusates

Shots: The US FDA has received a 510(k) application for the SmartTouch+ Sensor to detect infiltration & extravasation events associated with both clear and white-opaque fluids early The SmartTouch+ Sensor expands ivWatch’s monitoring to lipid-based fluids like TPN & propofol, with the Patient Monitor performing 18,000+ checks/hour to detect infiltration or extravasation & alert clinicians,…
August 19, 2026

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NEWS

Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

Shots: The P-III (LUCIDITY) trial assessed avexitide (90mg, SC, QD) vs PBO in 78 adults with Post-Bariatric Hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery  Trial met its 1EP, showing a 55% reduction in the composite rate of Level 2 & Level 3 hypoglycemic events through Wk. 16. All 2EPs were also met, with consistent, highly…
August 18, 2026

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NEWS

Biocon Secures FDA Approval for Yesintek (Biosimilar, Stelara) 

 Shots:  The US FDA has approved Yesintek 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors, a biosimilar version of Stelara (ustekinumab)  Yesintek is indicated for mod. to sev. plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older, and for mod. to sev. active Crohn’s disease and ulcerative colitis in adults  Yesintek was initially approved in November 2024  Ref: Biocon…
August 18, 2026

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