Sumitomo Pharma’s enzomenib receives FDA orphan drug designation for acute lymphoblastic leukemia
FDA orphan drug status expands enzomenib’s ALL pathway as Sumitomo Pharma advances pivotal development in biomarker-defined acute leukemia.
Pharma & Biotech
Pharma & Biotech
FDA approves Novartis Pluvicto for earlier treatment of PSMA-positive metastatic prostate cancer
The United States Food and Drug Administration (FDA) has approved Novartis Pharmaceuticals Corporation’s Pluvicto in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer, moving targeted radioligand therapy into an earlier stage of the disease. The July 31 approval covers patients whose metastatic cancer remains responsive
Medical Devices & Diagnostics
Picard Medical unveils Emperor electromechanical architecture for next-gen artificial heart
Picard Medical has publicly presented the integrated architecture of its Emperor Total Artificial Heart for the first time, revealing how a compact electromechanical drive system could eventually replace the external pneumatic equipment used to power the existing SynCardia Total Artificial Heart. The preliminary architecture was presented at the 48th Annual International Conference of the IEEE
Pharma & Biotech
FDA panel supports Replimune’s RP1 melanoma data after two regulatory rejections
A United States Food and Drug Administration (FDA) advisory committee has voted 10 to 3 that efficacy findings from Replimune Group’s IGNYTE study of RP1 plus nivolumab are evaluable and clinically meaningful, handing the experimental melanoma treatment a significant regulatory reprieve after two earlier rejection letters. The committee considered RP1, also known as vusolimogene oderparepvec,
Pharma & Biotech
UAE authorizes PRECISION-E2 trial of Teverelix for symptomatic endometriosis
UAE authorizes the PRECISION-E2 trial of Teverelix, combining estradiol suppression, symptom tracking and genomic analysis in endometriosis
Pharma & Biotech
New MIRACLE data examine remission after venetoclax failure in relapsed AML
MIRACLE reports a 37% blinded composite remission rate in relapsed AML, including patients who previously failed venetoclax treatment.
Pharma & Biotech
Ziltivekimab lowers inflammation but fails Phase 3 cardiovascular outcomes test
Ziltivekimab lowered IL-6 activity and hsCRP but failed to reduce major cardiovascular events in Novo Nordisk’s 6,300-patient ZEUS trial.
Pharma & Biotech
Can PVP Labs turn Taphalgin into a battlefield alternative to scheduled opioids?
PVP Labs will present Taphalgin at MHSRS 2026 as a battlefield pain candidate, but U.S. trials and FDA review remain decisive.
Medical Devices & Diagnostics
Can Canon Medical’s imaging reach turn eyonis LCS regulatory success into hospital adoption?
Median Technologies and Olea Medical will deploy eyonis LCS across United States and European lung cancer screening workflows.
Pharma & Biotech
How miRecule’s Rio Biofarma partnership could advance extrahepatic RNA delivery
miRecule and Rio Biofarma are pairing peptide delivery with RNA payloads, but clinical validation and scalable manufacturing remain ahead.