REGENXBIO has reported that the US FDA has placed a clinical hold on its investigational gene therapy, RGX-121, developed for the treatment of MPS II.

Analysts are heralding functional cures like Hibsago in chronic hepatitis B as the next frontier in treatment for patients.

Takeda has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orzeyful to treat narcolepsy type 1 in adults.

A desire for sustainable growth is pushing gene therapy biotechs to be strategic about manufacturing and pipelines.

Sandoz and Henlius will collaborate on up to 10 biosimilars amid opportunity to capitalise on global biosimilar loss-of-exclusivities.

A convergence of regulations across life sciences has shifted quality management from a burden into an imperative for excellence.

The EC has approved an extended use of Johnson & Johnson's Tecvayli, along with daratumumab, to treat adult patients with relapsed or refractory multiple myeloma (r/r MM).

Ultragenyx Pharmaceutical has received accelerated approval from the FDA for its gene therapy, Genglycos, to treat GSDIa.

WellSpan Health and Johns Hopkins Medicine have renewed their oncology collaboration to widen access to advanced care throughout central Pennsylvania, US.

Tanabe’s dersimelagon is already under FDA review having achieved positive Phase III results earlier this year.

Kynexis will now prepare for registrational studies on lead asset, KYN-5356 in cognitive impairment associated with schizophrenia (CIAS).

The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Eli Lilly’s Onswik (efsitora alfa) in a move that opens the insulin jab up for national ...