The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line ...

Antibody-drug conjugates have had a tremendous impact on breast cancer care and treatment, according to Dr. Charles E. Geyer.

In HER2-positive early breast cancer, Kadcyla shows sustained improvement in both invasive disease-free survival and overall survival versus Herceptin.

Sales of PBYI's sole-marketed drug, Nerlynx, exceeded management's expectations in fourth-quarter 2024. Also, ongoing studies on alisertib are progressing well.

extra time sitting to get a drug administered and more frequent office visits to monitor for side effects.” Trastuzumab (Herceptin, Genentech) and pertuzumab (Perjeta, Genentech) launched as IV ...

LUND, SE / ACCESS Newswire / March 20, 2025 /Alligator Bioscience (Nasdaq Stockholm:ATORX) today announces that the U.S. Food ...

For the study, investigators pitted the HER2-targeted antibody-drug conjugate against Eli Lilly ... cancer following prior treatment with a trastuzumab (Herceptin)-based regimen.

Radiopharm Theranostics Limited targets oncology with radiotherapeutics like Lu-RAD204 for NSCLC. Key 2025 data signals ...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal ...

The conversion from accelerated approval to traditional approval was supported by data from the phase 3 KEYNOTE-811 trial.

Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ advanced HER2+ BC based on results from the primary analysis, which the Company used to submit an NDA to the ...

Highlighted by Genentech's recent US regulatory submission for trastuzumab–DM1, antibody–drug conjugation technology ... “The post-approval study required by the FDA that combined ...