FDA approval moves trastuzumab deruxtecan in combination with pertuzumab into frontline treatment of unresectable or ...

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved additional indications for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary ...

The FLAMINGO-01 DSMB met twice in 2025, most recently in December 2025, and recommended to continue the study as is without modification. The Steering Committee also met at SABCS 2025 and discussed ...

The U.S. Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with ...

Patients should be selected for treatment with Enhertu in combination with pertuzumab based on confirmed HER2-positive status or HER2 gene amplification (IHC 3+ or ISH+).

The FDA approved T-DXd plus pertuzumab for HER2-positive metastatic breast cancer, based on DESTINY-Breast09 trial results. The combination therapy reduced disease progression or death risk by 44% ...

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01 ...

As of Wednesday, December 17, Greenwich LifeSciences, Inc.’s GLSI share price has surged by 5.19%, which has investors ...

-- 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile. -- The PIS elicited a ...

In another first, Sandoz launched in November 2025 the first FDA-approved biosimilar of Tysabri (natalizumab). Tyruko (natalizumab-sztn) is used to treat adult patients with relapsing multiple ...

A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate shows an approximately 80% reduction in recurrence rate in the fully enrolled, 250 patient ...

Previous findings from the phase 3 DESTINY-Breast05 study (NCT04622319) showed that T-DXd demonstrated statistically significant and clinically meaningful improvement vs T-DM1 in the primary endpoint ...