Orca Bio’s Orca-T FDA review extended to July 2026

Middle East disruption hits thousands of global clinical trials, Phesi warns

The impact on Phase III trials is particularly significant, as these later-stage studies involve larger, committed patient populations and represent years of investment

Rusan unveils APOSAN 3ml multi-dose pen

The company now offers the complete range of Apomorphine Hydrochloride in different fill volumes

Bavarian Nordic seeks EMA nod for Mpox vaccine in children aged 2–11

The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN

ENHERTU approved in China as first HER2-targeted ADC for early breast cancer

The decision is based on the phase 3 DESTINY-Breast11 trial

Teva hits major biosimilar milestones with FDA nod and regulatory filings

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia

Novo Nordisk India sets patient-centred price of Rs. 202/day for starting dose of Ozempic and Wegovy

Price of the starting dose of Ozempic and Wegovy reduced by 36% and 48% respectively

Rocket Pharma gets FDA nod for first pediatric gene therapy targeting severe LAD-I

The approval covers pediatric patients without a matched sibling donor for stem cell transplant

AstraZeneca’s breakthrough COPD drug Tozorakimab slashes flare-ups in landmark Phase III trials

High-level results from the Phase III OBERON and TITANIA trials revealed that the first-in-class monoclonal antibody reduced the annual rate of moderate-to-severe COPD exacerbations compared with placebo

Semaglutide not a “Quick Fix”: Top docs urge holistic approach as drug goes off patent in India

They stressed that while the drug is clinically proven to support weight and blood sugar control, it must be prescribed only after careful patient evaluation and used under strict medical supervision.