The agency approved the antibody-drug conjugate for treating HER2-positive neoadjuvant and adjuvant breast cancer alongside an IHC an ISH test for identifying best responders.
Sponsor Benitec anticipates formalizing its plan for a pivotal trial of BB-301 with the US Food and Drug Administration in mid-2026.
The firm said the preclinical data supports studying its lead candidate SIL-204 in combination with immunotherapy in KRAS-mutant pancreatic cancer.
The CELIA trial didn't meet its main goal of assessing dose response for change from baseline on a clinical dementia scale, but the ASO diranersen did lower tau levels and slow clinical decline.
The partners will incorporate Telix's PSMA-PET gallium 68-based imaging agents Gozellix and Illuccix with EDAP and Profound's technologies for minimally invasive treatment.
On CGTxchange, sponsors can list their shelved cell and gene therapies in the hopes that other investors, partners, and ...
The ex vivo therapies from BRL Medicine and Reforgene Medicine use different strategies to boost production of fetal hemoglobin.
Even though Arvinas and Pfizer appear to have "written off" the drug, in one analyst's view, Rigel believes it can drive adoption among community-treated patients lacking SERD access.
ETX101 reduced seizures and improved neurodevelopmental outcomes, but its impact was unexpectedly attenuated by using the ...
At the ASCGT meeting, scientists reported that Carvykti-treated cells overexpressed the enzyme Granzyme K, which may be ...
The firm said the epidermolysis bullosa cell therapy brought in $8.7 million in Q1 and that it will develop a prostate cancer cell therapy and deprioritize internal ophthalmology programs.
T therapy Aucatzyl could usher in profitability by 2028, CEO Christian Itin said, but growth from other disease areas will ...