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

Johnson & Johnson has submitted a NDA seeking approval from the FDA for icotrokinra to treat moderate to severe plaque psoriasis (PsO).

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.

Life sciences venture capital (VC) firm Omega Funds has closed its eighth fund, with capital commitments totalling $647m.

A successful monoclonal antibody could undergo scale-up several times across the span of its commercial life, each stage presenting new complexities during sterile fill-finish. As more sponsors turn ...

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

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 ...

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

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

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

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