The European Commission (EC) has approved an indication extension of Darzalex (daratumumab) subcutaneous (SC) formulation in ...

Australia’s Therapeutic Goods Administration (TGA) has accepted a court-enforceable undertaking from Your Solution ...

Neuromyelitis optica spectrum disorder (NMOSD) – also known as neuromyelitis optica (NMO) and Devic’s disease – is a rare, ...

A key result of recent European workshops is that drug studies should be designed in such a way that they address both ...

Landmark Bio brings to Artis state-of-the-art infrastructure and expertise in process development, analytical sciences, and ...

Japanese ophthalmology company Santen Pharmaceutical (TYO: 4536) said it has earned approval from Chinese regulatory, the ...

Danish patients with serious illnesses are increasingly gaining access to advanced therapy medicinal products (ATMPs). This ...

In the news last week, US Center for Biologics Evaluation and Research (CBER) Dr Peter Marks quit his post after reported ...

April 4, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost ...

The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) as the first and only treatment for adults ...

Swedish biotech OncoZenge (Nasdaq: ONCOZ) has expanded its regulatory team as it prepares for a Phase III trial of BupiZenge ...

The European Medicines Agency has temporarily suspended enrollment and dosing in a Phase II trial of Sarepta Therapeutics' ...