Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation

Cognita CXR leverages a proprietary vision-language model to analyze full chest X-ray studies and generate comprehensive preliminary findings

GAIA and Daiichi Sankyo Europe join forces to launch groundbreaking digital therapeutic for heart health

Germany will be the first launch market

Neuland to launch commercial peptide facility in Hyderabad as global capacity tightens

The first of four planned modules at the new plant is expected to come online by summer 2026

Avio Smart teams up with Huwel Lifesciences to roll out next-gen molecular diagnostics in India

Huwel’s diagnostic solutions leverage open RT-PCR system

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EU unveils draft guidance to fast-track clinical trials during public health emergencies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

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

FDA okays JUXTAPID for kids with ultra-rare genetic cholesterol disorder

Granules India’s US packaging facility clears FDA inspection with zero observations

The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices