News
Astra Zeneca's breast cancer drug fails to earn backing of FDA advisory committee
2+ hour, 23+ min ago (448+ words) A panel of independent advisors have recommended against approving Astra Zeneca's oral SERD drug camizestrant for certain breast cancer patients alongside a CDK4/6 inhibitor. The issue, the panelists contended, lies with Astra Zeneca's study design. In the Phase 3 SERENA-6 trial, the…...
Sim Bio Sys to Showcase New Advancements in AI-Powered Surgical Planning at the American Society of Breast Surgeons (ASBr S) Annual Meeting
1+ day, 19+ hour ago (542+ words) Bio Space Sim Bio Sys to Showcase New Advancements in AI-Powered Surgical Planning at the American Society of Breast Surgeons (ASBr S) Annual Meeting Company to unveil Tumor Sight" Viz 1. 4 and surgical outcome visualization capability, advancing precision and personalization in breast…...
Calidar Completes Enrollment in First-in-Human Study of 4 D Mammography System
2+ day, 5+ hour ago (546+ words) Bio Space Calidar Completes Enrollment in First-in-Human Study of 4 D Mammography System RESEARCH TRIANGLE PARK, N. C. , April 28, 2026 /PRNewswire/ -- Calidar, Inc. , an innovative start-up in precision diagnostic imaging, today announced the completion of enrollment in its first-in-human clinical study of the 4 D…...
Sibel Health Receives FDA-Clearance for ANNE" Maternal, a Comprehensive and Fully Wireless Maternal-Fetal Monitoring Platform
3+ week, 8+ hour ago (633+ words) Bio Space Sibel Health Receives FDA-Clearance for ANNE" Maternal, a Comprehensive and Fully Wireless Maternal-Fetal Monitoring Platform CHICAGO, April 9, 2026 /PRNewswire/ -- Sibel Health today announced FDA 510(k) clearance of ANNE" Maternal, the world's first fully wireless, comprehensive maternal-fetal monitoring platform. Designed for…...
Ending the Diagnostic Delay: Feinstein Institutes" ROSE Study Continues to Advance Critical Endometriosis Diagnostic Test
1+ mon, 22+ hour ago (226+ words) National Institutes of Health awards The Research Out Smarts Endometriosis team an $850, 000 prize over one year to accelerate the development of a non-invasive diagnostic test "Many women tell us they've been dismissed by doctors, friends, coworkers, and even parents," said…...
NBDF's Pathway to Cures Announces Spark Biomedical's LUNA Trial to Advance Non-Pharmaceutical Options for Heavy Menstrual Bleeding
1+ mon, 1+ week ago (557+ words) Bio Space NBDF's Pathway to Cures Announces Spark Biomedical's LUNA Trial to Advance Non-Pharmaceutical Options for Heavy Menstrual Bleeding Phase II decentralized study evaluates transcutaneous auricular neurostimulation (t AN) for heavy menstrual bleeding, including participants with inherited bleeding disorders NEW…...
Novartis Buys Breast Cancer Drug for $2 B to Keep Up With Myriad Rivals
1+ mon, 1+ week ago (241+ words) Novartis is picking up a breast cancer drug candidate from Delaware's Synnovation Therapeutics, a move that will help it stay ahead of big pharma peers playing in the PI3 K" arena. The front-heavy deal, announced in a Friday morning news release,…...
ENHERTU" (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer
1+ mon, 3+ week ago (808+ words) Based on DESTINY-Breast05 Phase III trial results which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1 If approved, Astra Zeneca and Daiichi Sankyo's ENHERTU has the potential to become a new standard of care…...
Cairn Surgical Announces Completion of Enrollment in U. S. Pivotal Trial of Novel Breast Cancer Locator System
3+ mon, 3+ week ago (593+ words) Bio Space Cairn Surgical Announces Completion of Enrollment in U. S. Pivotal Trial of Novel Breast Cancer Locator System LEBANON, N. H. --(BUSINESS WIRE)--#BCSM--Cairn Surgical, Inc. , an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that…...
Pfizer Builds Case for Tukysa as "New Standard Regimen" in First-Line Metastatic Breast Cancer
4+ mon, 2+ week ago (334+ words) Pfizer's oral kinase inhibitor Tukysa significantly cut the risk of death or disease progression in patients with metastatic breast cancer in the frontline setting. Tukysa's performance in this indication positions it to "become a new standard regimen" in HER2-positive metastatic…...