In the warning letter, the FDA alleged that Novo inadequately responded to observations made after an inspection in 2025.
These UK-led efforts to support foreign infectious disease trials come after the US pulled foreign research aid to home in on domestic health ...
The investment in China follows similar outlays by the drugmaker in other regions as it prepares for high orforglipron demand.
Uğur Şahin and Özlem Türeci established BioNTech in 2008 – the husband-and-wife team currently serve as CEO and chief medical officer, respectively. In its full year 2025 results, BioNTech said the co ...
Idorsia has signed an exclusive deal with Pharmalink Drug Store to distribute and commercialise its Quviviq therapy in various Gulf states.
The FDA has granted approval for the expanded use of GSK’s Wellcovorin to treat CFD in patients with a confirmed variant in the FOLR1 gene.
This new framework is the FDA's second scheme designed to streamline biosimilar development in the hopes of lowering drug prices.
Dubai is building life sciences clusters and research hubs, aiming to be a resilient healthcare and innovation center in a region facing ongoing conflict.
According to GlobalData, US vaccine manufacturers could be significantly hit by the reduced immunisation demand.
Junshi Biosciences has received acceptance from China’s NMPA for toripalimab JS001sc NDAs covering 12 indications for cancer treatment.
Novo Nordisk and Hims & Hers have come to an agreement that will see the telehealth company sell Novo’s branded glucagon-like peptide-1 receptor agonists (GLP-1RAs), ending a lo ...
NewcelX has signed a collaborative research agreement with Eledon Pharmaceuticals to advance its NCEL-101 programme for type 1 diabetes.