AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)

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

Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients

The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies

FDA nod to AstraZeneca’s Imfinzi plus FLOT chemotherapy for early and locally advanced gastric cancer

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study

AstraZeneca’s Imfinzi cuts death risk by 32% in high-risk non-muscle-invasive bladder cancer

Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study

Enhertu improved in invasive disease-free survival in early breast cancer in DB-05

Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting

Fortis and Agilus expand rapid genomic testing capabilities

The Genexus platform enables Next-Generation Sequencing with significantly faster turnaround times