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 reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available

Zydus receives FDA’s tentative approval for Dapagliflozin Tablets

Novo Nordisk weathers pricing pressure, bets big on oral Wegovy

Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates

GPT Healthcare reports 12% revenue growth in 9M FY26, strengthens clinical capabilities

The company maintained a competitive ARPOB while steadily improving occupancy, driven by higher patient volumes and efficient capacity utilization

Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease

Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs

FDA launches PreCheck program to bring drug manufacturing back to US

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites

Richter’s FYLREVY to transform menopause care in Europe?

The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses

ALX Oncology’s evorpacept shows promise in HER2-positive breast cancer

The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy

Siemens Healthineers launches €10 million R&D hub in Swords, Ireland

The facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders