The FDA has granted Breakthrough Therapy Designation to Gilead's Trodelvy for second-line treatment of extensive-stage small cell lung cancer, based on promising results from the Phase 2 TROPiCS-03 study
The Phase 3 PATINA study shows that Ibrance, combined with standard therapies, extends progression-free survival by over 15 months in HR+/HER2+ metastatic breast cancer
New data presented at ASH 2024 show that Roche's Columvi and Lunsumio significantly improve outcomes for lymphoma patients, offering durable remissions and flexible treatment options
A Phase II study showed that quizartinib, developed by Astellas and Ambit Bioscience, is effective as an oral monotherapy for relapsed or refractory acute myeloid leukemia (AML) patients
The European Commission has approved Vabysmo (faricimab) pre-filled syringe for treating neovascular or 'wet' age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion
The European Medicines Agency's CHMP has issued a positive opinion for Celltrion's Eydenzelt, an aflibercept biosimilar, for treating serious retinal diseases
The CHMP has recommended approval of CSL Behring and Arcturus’ Kostaive, a self-amplifying mRNA vaccine, for the prevention of COVID-19 in adults. This recommendation is based on positive results from clinical trials showing its effectiveness in reducing symptomatic COVID-19 cases.
NICE UK grants managed access for Elrexfio to treat relapsed/refractory multiple myeloma after three treatments
Results from the Phase III NATALEE trial show that Kisqali (ribociclib) combined with endocrine therapy significantly reduces recurrence in HER+/HER2- early breast cancer
The Phase III CARTITUDE-4 study results show that a single infusion of Carvykti (ciltacabtagene autoleucel) significantly increased minimal residual disease negativity rates in patients with multiple myeloma