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 ...

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

J&J will use a 160,000ft² manufacturing facility at Fujifilm’s new manufacturing hub in Holly Springs, North Carolina. Credit ...

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 ...

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

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

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

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

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

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

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