13/01/2026 Ipsen's IPN60340 received the FDA Breakthrough Therapy Designation for AML Ipsen's IPN60340 received the FDA Breakthrough Therapy Designation for AML (Ref) The US FDA granted the Breakthrough Therapy Designation to Ipsen's IPN60340 (anti-BTN3A) in combination with venetoclax and azacitidine in first line unfit acute myeloid leukemia. Christelle Huguet, PhD, EVP and Head of R&D, Ipsen: “This Breakthrough Therapy Designation recognizes both the urgent need for new tr

10/12/2025 GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC Ajax Therapeutics' AJ1-11095 received the FDA orphan drug designation for myelofibrosis GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC (Ref) The US FDA granted the orphan drug designation to GSK's risvutatug rezetecan (B7-H3-targeted ADC) for the treatment of small-cell lung cancer (SCLC). The ODD was based on preliminary clinical data of the Phase 1 ARTEMIS-0

20/08/2025 Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer (Ref) The US FDA granted the Orphan Drug Designation to Invion's INV043 (photodynamic therapy) for the treatment of anal cancer. Invion is working with Peter Mac to conduct an trial of INV043 in combination with ICIs in anogenital cancer including anal, vulvar and penile cancers Prof Thian Chew, Executive Chairman and CEO, Invion: “This regulatory milestone enhances our ability to bring INV0