The United States Food and Drug Administration (FDA) has approved MannKind Corporation’s Furoscix ReadyFlow, a prefilled autoinjector that delivers 80 milligrams of subcutaneous furosemide in about ten seconds for adults experiencing edema associated with chronic heart failure or chronic kidney disease. The July 24 approval creates a faster alternative to the existing Furoscix On-body Infusor,
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
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
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,
Vector, LyoGenesis Plus and Wynn plan IV bag and vial adapter products, but definitive agreements and regulatory pathways remain ahead.
Johnson & Johnson proposes a $5.5 billion deal for 76,000 ovarian talc claims, but participation, future lawsuits and costs remain critical.
Otsuka will unveil two-year VISIONARY eGFR data for VOYXACT, a pivotal test of kidney preservation and its path to full FDA approval.
Precision BioSciences reshapes leadership to support PBGENE-HBV and PBGENE-DMD as two gene-editing trials approach key 2026 milestones.
Roche’s cobas BV/CV assay gains FDA clearance for combined BV and Candida testing, setting up a 2026 U.S. laboratory launch.
Arrowhead’s Phase 3 SHASTA data show deep triglyceride reductions and fewer pancreatitis events, supporting a planned 2026 U.S. filing.