FDA approves lurbinectedin plus atezolizumab for ES-SCLC maintenance, extending OS to 13.2 months vs 10.6 months with atezolizumab alone (HR 0.73, p=0.0174).

FDA grants Priority Review for Enhertu plus pertuzumab in first-line HER2+ metastatic breast cancer, with decision expected April 2025.

FDA approves gemcitabine intravesical system for BCG-unresponsive bladder cancer, showing 82% complete response rate in SunRISe-1 trial.

Modeyso, the first treatment option for this ultra-rare and aggressive brain tumor, is commercially available in the US.

Verzenio plus endocrine therapy offers statistically significant OS improvements over endocrine therapy alone in high-risk patients.

The FDA has issued a Complete Response Letter for TLX250-CDx (Zircaix), rejecting the biologics license application for this breakthrough therapy-designated PET imaging agent due to chemistry, manufacturing, and controls deficiencies rather than clinical efficacy concerns. Telix believes these manufacturing comparability issues are readily addressable, maintaining the drug’s potential as the first commercial imaging agent for […]

FDA expands Pluvicto for earlier use while PARP inhibitors show benefit in BRCA1/2+ patients, advancing precision prostate cancer care.

Zongertinib becomes first oral HER2-targeted therapy for NSCLC, achieving 75% response rate in previously treated patients.