Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug ...

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

TCG Labs Soleil, which launched in 2024 in collaboration with The Column Group, is focused on building single-drug biotechs ...

The Swiss company, which markets Elevidys abroad, said it believes the benefit-risk balance to treatment remains positive in ...

The French biotech is developing a new drug approach in a disease market that’s projected to grow to $30 billion by 2030.

The pharmaceutical giant sees the drug, gefurulimab, as a more convenient, self-administered alternative to the infused ...

The $50 billion target, which AstraZeneca plans to meet by 2030, includes new manufacturing projects in Virginia and ...

Leveraging a CDMO’s established platform for AAV manufacturing can significantly streamline gene therapy development.

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater than currently accepted.

The startup is using elements of gene and cell therapy to create medicines that could be useful against an array of ...