15/12/2025 Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer FibroGen's roxadustat received the FDA Orphan Drug Designation for myelodysplastic syndromes Eli Lilly's TECVAYLI plus DARZALEX FASPRO combo has been selected for the FDA's CNPV Pilot program Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer ( Ref ) The US FDA granted ap

08/12/2025 Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer ( Ref ) The US FDA granted the orphan drug designation to Chimeric Therapeutics' CHM CDH17 (CDH17-targeting CAR-T cell therapy) in the treatment of Gastric Cancer. Dr Rebecca McQualter, CEO, Chimeric Therapeutics: “ This is a great step forward in the development of CHM CDH17 to ser

07/12/2025 In Ph3 trial, Lilly's Jaypirca met its primary endpoint of ORR in CLL/SLL In Ph3 trial, Lilly's Jaypirca met its primary endpoint of ORR in CLL/SLL ( Ref ) The Phase 3 BRUIN CLL-314 trial of Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) met its primary endpoint of non-inferiority on ORR vs ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve. ORR: 87.0%

06/11/2025 Johnson & Johnson's Darzalex Faspro has been approved by the FDA for HR-SMM ( Ref ) The US FDA approved Johnson & Johnson's Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). The approval is based on results from the Ph3 AQUILA/NCT03301220 trial, which evaluated the efficacy and safety of Darzalex Faspro vs active monitoring (or “Watch and Wait”) in patients with

30/10/2025 Lantheus received FDA PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit ( Ref ) The US FDA established a PDUFA date for Lantheus Holdings' LNTH-2501 (Gallium-68 edotreotide) diagnostic kit indicated for use with PET imaging for localization of SSTR+ neuroendocrine tumors in adult and pediatric patients. The FDA has set a PDUFA target action date of March 29, 2026 Brian Markison, CEO, Lantheus: “ The development of LNTH-2501 underscores our

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction ( Ref ) Genmab and Merus announced a transaction...

08/09/2025 Beyond Air's BA-101 received the Orphan Drug Designation for GBM ( Ref ) The US FDA granted the Orphan Drug Designation to...

05/09/2025 CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML ( Ref ) The US FDA granted the Fast Track...

04/09/2025 Eli Lilly and Company's olomorasib in combination with Keytruda received the FDA Breakthrough Therapy designation...

03/09/2025 Boehringer Ingelheim's zongertinib received the FDA Breakthrough Therapy Designation for first-line HER2-mutant advanced NSCLC...

20/08/2025 Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer ( Ref ) The US FDA granted the Orphan Drug...

06/08/2025 Jazz Pharmaceuticals' Modeyso received accelerated approval from the FDA for Recurrent H3 K27M-mutant Diffuse Midline Glioma (...

11/07/2025 Cel-Sci to partner with a leading Saudi Arabian pharma company for Multikine in the Tx of Head & Neck Cancer ( Ref ) Cel-Sci...

08/07/2025 Adagene and ConjugateBio sign a partnership agreement to develop novel ADC ( Ref ) Adagene announced a partnership with...

01/07/2025 HanchorBio and Henlius signed a ~$200M licensing deal for HanchorBio's HCB101 ( Ref ) HanchorBio and Shanghai Henlius Biotech...