Before Novo arrived as its owner, issues at the Bloomington facility caused a two-month delay for Eylea HD’s FDA approval decision in 2023. In November 2024, the FDA also found quality control lapses ...

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

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

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

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

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

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

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 ...

Santen has signed an agreement with RemeGen for the RC28-E intravitreal injection, a dual-target fusion protein for retinal ...

Sanofi has received orphan designation from the EMA for rilzabrutinib, a reversible covalent BTK inhibitor, to treat IgG4-RD.