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NEWS

Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Shots:The US FDA has approved OncoMate MSI Dx Analysis System as a companion diagnostic to identify pts with microsatellite stable endometrial carcinomaThe OncoMate MSI Dx Analysis System is a PCR-based assay that determines MSI status in tumors to identify pts eligible for treatment with Keytruda (pembrolizumab) & Lenvima (lenvatinib)OncoMate MSI Dx Analysis System…
4 hours ago

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NEWS

Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Shots:The Chinese NMPA has approved PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib)The kit was validated through a large-scale study across 33 tumor types & 2,400+ clinical samples, where it demonstrated high accuracy, sensitivity, & reproducibility, with detection of 200+ unique NTRK fusion variantsAlso, clinical bridging studies…
1 day ago

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 03, 2025 – Nov 07, 2025)

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:    Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC Read More: Daiichi Sankyo Genentech Reports P-III (ALLEGORY) Trial…
November 7, 2025

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Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty

Shots:Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG)EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure timesThe company has planned to launch EndoZip in select EU centers &…
November 7, 2025

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UroViu Receives European CE Certification for its Cystoscope and Hysteroscope Portfolio

Shots:UroViu has received European CE Mark approval for its cystoscope & hysteroscope portfolio, incl. the reusable UV5000w Wi-Fi Handle & disposable Hystero-V, Uro-V, & Uro-GHD endoscopesUroViu’s portfolio has shown strong clinical value & efficiency in cystoscopy procedures, incl. diagnosis, cancer surveillance & minor therapeutic interventions, as highlighted in data presented at EAU &…
November 7, 2025

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NEWS

Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes

Shots:Aqua Medical has received the US FDA IDE approval to initiate the RESTORE-1 study evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure using its radiofrequency vapor ablation (RFVA) system in adults with uncontrolled type 2 diabetesThe IDE approval was backed by international data showing safety & metabolic benefits of PIMA, allowing Aqua Medical…
November 6, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 27, 2025 – Oct 31, 2025)

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:   Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic SyndromeRead More: RocheMerck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear…
October 31, 2025

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NEWS

Avvio Medical’s Avvio Enhanced Lithotripsy System (ELS) Receives the US FDA’s Breakthrough Device Designation (BDD) for Kidney Stone Treatment

Shots:The US FDA has granted BDD to Avvio ELS for minimally invasive, anesthesia-independent kidney stone treatmentAVVIO ELS will be investigated in a pivotal ELS trial across the US following IDE approval, with US commercial launch planned in 2026, pending FDA clearanceThe AVVIO ELS uses microbubble-enhanced acoustic cavitation lithotripsy to enable minimally invasive kidney…
October 29, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 21, 2025 – Oct 24, 2025)    

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:   Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Read More: Daiichi Sankyo and Merck Gilead…
October 24, 2025

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