IceCure Medical’s ProSense Cryoablation System Receives the US FDA Marketing Authorization for Breast Cancer

Shots: The US FDA granted De Novo marketing authorization to ProSense cryoablation system for treating women (≥70yrs.) with biologically low-risk breast tumors (≤1.5cm) on adjuvant endocrine therapy ProSense is a minimally invasive cryosurgical tool that uses liquid nitrogen to freeze & destroy tumors in breast, kidney, lung & liver, with similar safety & efficacy observed…

ByRidhi RastogiOctober 6, 2025

NEWS

Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots: The EMA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab), following the MHRA’s MAA acceptance earlier this year AVT23 was jointly developed by Alvotech & Kashiv BioSciences, with Advanz Pharma obtaining commercial rights to AVT23 in the EEA, UK, Switzerland, Canada, Australia and New Zealand Omalizumab is a humanized mAb that…

ByRidhi RastogiOctober 6, 2025

NEWS

AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer

Shots: The global P-III (TROPION-Breast02) trial assessed Datroway vs CT in 644 pts with previously untreated locally recurrent inoperable or metastatic TNBC, regardless of PD-L1 expression, for whom immunotherapy was not an option Trial showed Datroway significantly improved OS & PFS vs CT in TNBC pts; data to be presented in a future meeting &…

ByRidhi RastogiOctober 6, 2025

NEWS

Roche and KlinRisk Secure CE Mark for Kidney Klinrisk Algorithm and Unveil CKD Algorithm Panel

Shots: Roche & KlinRisk have received CE-mark approval for the AI-based Kidney Klinrisk Algorithm to assess progressive kidney function decline, integrated into the navify Algorithm Suite The chronic kidney disease algorithm panel combines the new Klinrisk Algorithm for early risk assessment with the CE-marked KFRE Algorithm for later disease stages, supporting care across the full…

ByRidhi RastogiOctober 6, 2025

NEWS

Santhera Pharmaceuticals Reports Health Canada’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

Shots: Health Canada has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy under priority review Approval was based on VISION-DMD study, which met its 1EP of Time to Stand (TTSTAND) velocity vs PBO at 24wks. of treatment, plus showed favorable safety & tolerability in pts Kye Pharma secured exclusive Canadian rights…

ByRidhi RastogiOctober 6, 2025

NEWS

Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US

Shots: Celltrion has launched Avtozma IV, a biosimilar to Actemra (tocilizumab) for all the approved indications of the reference product in the US In Jan 2025, the FDA approved Avtozma based on a global P-III trial showing comparable efficacy, PK, safety & immunogenicity vs reference tocilizumab, followed by an additional July 2025 FDA approval for…

ByRidhi RastogiOctober 6, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 29, 2025 – Oct 03, 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 & AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer Read More: Daiichi Sankyo & AstraZeneca Merck Presents P-III (HYPERION) Trial Data…

ByRidhi RastogiOctober 3, 2025

NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA’s sBLA Acceptance of Enhertu Regimen for HER2+ Breast Cancer

Shots: FDA has accepted an sBLA of neoadj. Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) for the treatment of adults with HER2+ (IHC 3+ or ISH+) stage 2/3 breast cancer (PDUFA: May 18, 2026) sBLA was backed by the P-III (DESTINY-Breast11) trial assessing neoadj. Enhertu alone (5.4mg/kg) ± THP vs ddAC + THP in…

ByRidhi RastogiOctober 3, 2025

NEWS

Amgen Reports P-III (VESALIUS-CV) Trial Findings on Repatha (Evolocumab) to Reduce Cardiovascular Risk in Adults

Shots: Amgen has reported the global P-III (VESALIUS-CV) trial findings assessing Repatha vs PBO, both in addition to optimized lipid-lowering therapy in adults (n >12,000) at high CV risk without prior heart attack or stroke At an mFU of 4.5yrs., the trial met its co-1EPs of time to first occurrence of composite of coronary heart…

ByRidhi RastogiOctober 3, 2025

NEWS

Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

Shots: Hologic has received the US FDA’s 510(k) clearance & European IVDR CE Mark approval for its Panther Fusion Gastrointestinal (GI) Bacterial & Expanded Bacterial Assays Panther Fusion GI assays quickly detect key bacterial pathogens causing infectious gastroenteritis, incl. Salmonella, E. coli (incl.O157), Campylobacter, Shigella, Vibrio, Yersinia, & Plesiomonas, using customizable molecular mini-panels to allow…

ByRidhi RastogiOctober 3, 2025

Ridhi Rastogi

IceCure Medical’s ProSense Cryoablation System Receives the US FDA Marketing Authorization for Breast Cancer

Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer

Roche and KlinRisk Secure CE Mark for Kidney Klinrisk Algorithm and Unveil CKD Algorithm Panel

Santhera Pharmaceuticals Reports Health Canada’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US

PharmaShots Weekly Snapshots (Sep 29, 2025 – Oct 03, 2025)

Daiichi Sankyo and AstraZeneca Report the US FDA’s sBLA Acceptance of Enhertu Regimen for HER2+ Breast Cancer

Amgen Reports P-III (VESALIUS-CV) Trial Findings on Repatha (Evolocumab) to Reduce Cardiovascular Risk in Adults

Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

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