FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients

The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy

Dr. David Berman to Join Moderna as Chief Development Officer

Over a two-decade career, Dr. Berman has worked on more than a dozen clinical-stage immunotherapies, including senior leadership roles in developing four oncology biologics

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage

Medera doses final patient in high-dose HFpEF gene therapy trial

Heart failure affects an estimated 64.3 million people worldwide

Senhwa Biosciences launches groundbreaking trial for HER2-positive tumours

CX-5461 is “the world's first and most advanced G-quadruplex (G4) stabilizer in development

ENHERTU gains first-ever nod in China for metastatic breast cancer

The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care

LATIFY Phase III trial of Ceralasertib fails to improve survival in advanced lung cancer

The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy

FDA nod to Koselugo for adults with Rare NF1 tumors, expanding life-changing treatment

Trump clinches historic deal as Lilly, Novo slash U.S. weight-loss drug prices

Agreements mark a major victory in the President’s long-term pledge to lower prescription drug costs for Americans