July 1st Week, 2025 Regulatory Updates 🎯 The US FDA granted accelerated approved for Dizal Pharmaceutical’s sunvozertinib (EGFR TKI) for the Tx of adult patients with LA/M NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemo. (Ref 1) ❓ How does sunvozertinib compare with Johnson & Johnson’s previously approved Rybrevant (amivantamab)? 🎯 The US FDA granted accelerated approval for Regeneron's linvoseltamab-gcpt (BCMA

Highlights from the CHMP Apr 2025 Meeting are out! ⭐ New Medicines 💊 Jazz Pharmaceuticals and BeiGene's zanidatamab (Ziihera; dual HER2-targeted BsAb) monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2+ve biliary tract cancer previously treated with at least one prior line of systemic therapy ⭐ New Biosimilars 💊 CuraTeQ Biologics' trastuzumab (Dazublys; HER2 inhibitor) is indicated for the treatment of HER2+ve metastat