Due to concerns surrounding its effectiveness, the US Food and Drug Administration (FDA) ended the Rare Pediatric Disease Designation (RPDD) programme in late 2024.

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 ...

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

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

In a recent webinar, industry experts explain how real-world data and patient-centric support can shape regulatory success ...

GSK has concluded the acquisition of efimosfermin alfa, an investigational therapeutic for serious liver disease (SLD), from Boston Pharmaceuticals in a $2bn deal. The transaction ...

The Swiss Agency for Therapeutic Products (Swissmedic) has approved Novartis’ Coartem (artemether-lumefantrine) Baby, described as the first malaria medicine for newborns and young infants. Known as ...

Otsuka Pharmaceutical has signed an agreement to acquire all assets related to Cantargia's early-clinical stage CAN10 programme.

With the aim of being the largest life science sector by 2035 behind only the US and China, the UK government is ramping up commercialisation.

Ultragenyx Pharmaceuticals has announced the extension of approval by Health Canada for Evkeeza (evinacumab) for HoFH.

The White House’s decision to safeguard $400m in President’s Emergency Plan for AIDS Relief (PEPFAR) funding to support the global human immunodeficiency virus (HIV) emergency provides “hope” to ...