The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with ...

Daiichi Sankyo and MSD have voluntarily withdrawn the biologics licence application (BLA) in the US for their HER3-directed ...

Canadian clinical-stage biotech Zymeworks (Nasdaq: ZYME) today announced that the National Medical Products Administration ...

(SMMT) stock rises as its lung cancer drug ivonescimab with chemotherapy hit the main goal in a Phase 3 trial for lung cancer ...

Intellia stock tanks after a patient in its phase III study evaluating gene therapy candidate nex-z in ATTR-CM experiences serious liver enzyme elevation.

Intellia's news comes at a challenging time for gene therapies, as multiple serious adverse events and fatalities have been ...

Summit Therapeutics' Phase 3 trial met the primary goal in lung cancer, showing significant PFS benefit with ivonescimab plus ...

In its first global phase 3 readout, Akeso and Summit Therapeutics’ closely watched PD-1xVEGF bispecific antibody ivonescimab ...

PFS in Phase 3 HARMONi study was met with statistical significance, but OS was not. Click here to find out why SMMT stock is ...

China's anti-graft watchdog is investigating Bi Jingquan, the former head of the China Food and Drug Administration. | ...

The mixed results showed that ivonescimab plus chemotherapy reduced the risk of disease progression or death by 48% compared to chemotherapy alone. Summit Therapeutics announced its intention to file ...

Summit now intends to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration seeking approval ...