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Jul 21, 2026
FDA approved zenocutuzumab-zbco (Bizengri) for NRG1 fusion-positive cholangiocarcinoma on May 8, 2026. The eNRGy trial showed a 36.8% ORR. It also received priority review, breakthrough, and orphan designations.
Jun 13, 2026
The FDA approved pivekimab sunirine-pvzy (Decnupaz) for adults with BPDCN on May 27, 2026, based on CADENZA trial data showing a 69.7% CR/CRc rate in treatment-naïve patients.
Mar 15, 2026
Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.
Mar 06, 2026
The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
Mar 09, 2026
A major meta-analysis of 19 randomized trials involving 123,940 participants found that only six side effects are actually caused by statins, challenging long-standing concerns about the drugs' safety profile.
