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EU unveils draft guidance to fast-track clinical trials during public health emergencies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

Roche’s experimental obesity drug shows strong weight-loss results in mid-stage trial

The company announced positive topline data from the Phase II ZUPREME-1 trial

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

Alembic enters US branded market with first sales of Pivya UTI treatment

Pivya is Alembic’s first branded pharmaceutica product in the US and is being marketed through Alembic Therapeutics LLC

Moderna strikes $950 million global settlement with Arbutus & Genevant, clears legal hurdles for vaccine pipeline

Moderna will appeal to the Federal Circuit to assert that its government-contractor immunity limits liability under federal law

Theravance Biopharma winds down Ampreloxetine programme after Phase 3 miss

AbbVie’s Risankizumab shows strong results in hard-to-treat Crohn’s disease patients

This study evaluated a difficult-to-treat Crohn's disease patient population