The FDA, which was originally going to make a decision by 19 August, has now pushed the target action dates back to Q4 2025.

Keros received orphan drug designation from the US FDA for its investigational therapy KER-065 to treat Duchenne muscular ...

In June 2022, Enanta filed a lawsuit against Pfizer in a US district court in Massachusetts, claiming that the big pharma ...

Madrigal Pharmaceuticals’ Rezdiffra has been approved in Europe for the treatment of MASH with moderate to advanced liver ...

Biotechnology company āshibio has entered an exclusive licensing agreement with Mereo BioPharma for the monoclonal antibody, ...

The FDA has rejected vatiquinone, requesting that PTC run an additional study to prove the drug's efficacy prior to ...

Bristol Myers Squibb and SystImmune have announced breakthrough therapy designation from the US Food and Drug Administration ...

The European Commission (EC) has granted marketing authorisation to SpringWorks Therapeutics, a subsidiary of Merck KGaA, for ...

CSL’s headcount reduction and vaccine spinoff dragged shares down 9.5%, from A$271.32 at market close on 18 August to ...

Global orphan drug sales are on the rise. To dodge potential pitfalls associated with reaching ultra-rare populations, ...

Novo is far from the only big pharma company bolstering DTC medicine offerings. Novo’s main rival in the GLP-1RA arena, Eli ...

Viking's obesity pill VK2735 met its primary endpoint but failed to outdo competitors Novo Nordisk and Eli Lilly in body ...