FDA homes in on biosimilar accessibility in new draft guidance
The US Food and Drug Administration (FDA) has further updated its regulatory framework around biosimilar medicines in a bid to…
10 Mar 2026
Junshi receives China’s NMPA acceptance for toripalimab injection
Junshi Biosciences has received acceptance from China’sNational Medical Products Administration (NMPA) for toripalimab subcutaneous injection (JS001sc) new drug applications (NDAs) covering 12 indications for cancer treatment. This marks the first…
10 Mar 2026
Novo and Hims & Hers become partners to end legal feud
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 long-running feud that…
10 Mar 2026
NewcelX and Eledon partner for NCEL-101 programme
NewcelX has signed a collaborative research agreement with Eledon Pharmaceuticals to advance its NCEL-101 programme for type 1 diabetes (T1D). The collaboration will integrate NewcelX’s NCEL-101 with Eledon’s investigational anti-cluster…
09 Mar 2026
GSK sells liver disease drug candidate to Alfasigma for $690m
Alfasigma has agreed to buy the global rights to GSK’s experimental liver disease drug in a deal worth up to $690m. As per the agreement, Italy-based Alfasigma will acquire worldwide…
09 Mar 2026
Vinay Prasad to leave the FDA again
Vinay Prasad is once again set to depart from his role at the US Food and Drug Administration (FDA), after just eight months back at the helm of the agency’s…
09 Mar 2026
Sciwind secures China’s NMPA approval for Ecnoglutide injection
Sciwind Biosciences has received China’s National Medical Products Administration (NMPA) approval for its Ecnoglutide injection for chronic weight management. Ecnoglutide is a cyclic adenosine monophosphate (cAMP)-biased glucagon-like peptide-1 (GLP-1) receptor…