Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

Biogen has announced plans to invest an additional $2bn in Research Triangle Park (RTP) in the US state of North Carolina. The latest manufacturing investment will support the ongoing development of ...

Now is the time to invest in quantum literacy, explore proof-of-concept collaborations and monitor quantum’s integration.

Fangzhou has signed a MoU with Novo Nordisk to collaborate on the management of serious chronic diseases, including obesity and diabetes.

Sanofi has completed its acquisition of Blueprint, enhancing its portfolio with a commercialised therapy and expertise focused on SM.

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

This CDMO insights podcast series continues with a discussion on how the complexities of gene therapies require unique technical expertise, and why early planning with the right partner can help keep ...

Thermo Fisher Scientific has signed an agreement for the acquisition of Sanofi’s steriles manufacturing site in Ridgefield, New Jersey, US.

Sarepta Therapeutics is set to cut 500 jobs as part of its restructuring and pipeline prioritisation plan, which is expected to result in annual cash cost savings of $120m in 2026. With its pipeline ...

As one FDA initiative works to sustain the momentum of rare disease research, other events threaten to slow progress.

The FDA’s Oncologic Drugs Advisory Committee has voted against the benefit/risk profile of GSK’s Blenrep just days before the drug’s PDUFA date.

FDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.