FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population

EU unveils draft guidance to fast-track clinical trials during public health emergencies

The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations

DiaMedica bags Health Canada nod for Phase 2 preeclampsia trial

DiaMedica said it plans to launch the trial later in 2026

SEQSTER launches 1-Click DataLake, unlocking real-world health data from 150M+ patients

The company says those insights can power advanced analytics and real-world evidence (RWE), helping researchers improve trial design, study feasibility, and recruitment strategies

Lonza to sell capsules & health ingredients business for $3 billion in major strategic shift

Lupin receives two observations from USFDA for Ankleshwar facility

The company will address the observations and respond to the U.S. FDA within the stipulated timeframe

FDA nod to groundbreaking combo therapy for relapsed multiple myeloma

This new treatment option can redefine how we approach RRMM treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile

Roche’s Gazyva shows breakthrough results in Lupus phase III trial

Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints

Evogene narrows focus to AI-driven molecule discovery after major strategic overhaul

Evogene said ChemPass AI was significantly expanded during 2025 through internal development and collaborations with Google Cloud

Liberate Bio bags key CAR-M patents, eyes first clinical trials in 2026

The licensed intellectual property covers methods and designs for CAR constructs engineered to function in myeloid cell populations