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

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.

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

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 ...

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 ...