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Shots: FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in…

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Sep 2025

NEWS

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Shots: The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025…

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Sep 2025

NEWS

Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

Shots: The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers Approval…

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Sep 2025

VIDEO

LIFE SCIENCES | DAILY NEWS | SEP 25, 2025 | PHARMASHOTS

25

Sep 2025

NEWS

Acadia Pharmaceuticals Reports Topline P-III (COMPASS PWS) Trial Data of Carbetocin for Hyperphagia in Prader-Willi Syndrome

Shots: Acadia Pharmaceuticals has reported topline P-III (COMPASS PWS) trial data of carbetocin (ACP-101; intranasal) in pts with hyperphagia in Prader-Willi syndrome The global trial evaluated carbetocin (3.2mg, TID) vs…

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Sep 2025

NEWS

ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Shots: ClearNote Health has received the UKCA certification for its Avantect Multi-Cancer & Ovarian Cancer tests to detect multiple cancers & support early diagnosis of ovarian cancer, respectively The Multi-Cancer…

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Sep 2025

NEWS

Smart Meter Launches iAmbientHealth for Remote Patient Monitoring

Shots: Smart Meter has launched iAmbientHealth to passively track heart rate, respiration, movement & bed exits without wearables or cameras iAmbientHealth provides continuous real-time health insights & predicts health events…

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Sep 2025

NEWS

Hansa Biopharma Reports Topline P-III (ConfIdeS) Trial Data of Imlifidase in Kidney Transplantation

Shots: Hansa Biopharma has reported topline P-III (ConfIdeS) trial data assessing imlifidase vs control for 12mos. in 64 kidney transplant pts (cPRA ≥99.9%) across 25 US sites Trial met its…

25

Sep 2025

NEWS

Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Shots: The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC) Designation was based on the P-I/II…

25

Sep 2025

NEWS

Kashiv BioSciences and JAMP Pharma Launch Pexegra (Biosimilar, Neulasta) and Filra (Biosimilar, Neupogen) in Canada

Shots: Kashiv BioSciences & JAMP Pharma have launched Pexegra & Filra, biosimilar version of Neulasta & Neupogen, respectively, in Canada JAMP Pharma & Kashiv BioSciences entered an exclusive agreement to…

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

LIFE SCIENCES | DAILY NEWS | SEP 25, 2025 | PHARMASHOTS

Acadia Pharmaceuticals Reports Topline P-III (COMPASS PWS) Trial Data of Carbetocin for Hyperphagia in Prader-Willi Syndrome

ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Smart Meter Launches iAmbientHealth for Remote Patient Monitoring

Hansa Biopharma Reports Topline P-III (ConfIdeS) Trial Data of Imlifidase in Kidney Transplantation

Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Kashiv BioSciences and JAMP Pharma Launch Pexegra (Biosimilar, Neulasta) and Filra (Biosimilar, Neupogen) in Canada

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