The US Food and Drug Administration has announced new guidance for drug applications that include results from adaptive clinical trials.
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The investigational broadly neutralising antibody, N6LS, is to be developed by ViiV Healthcare for the treatment and prevention of HIV-1.
A recent industry report projects a boom in the biosimilars market over the next three years and highlights key considerations for meeting its potential.
Givlaari (givosiran) has been approved by the FDA for the treatment of adult patients with the rare genetic disorder, acute hepatic porphyria.
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
Authorisation has been granted in the UK for the STEADFAST clinical study of TX200, which is the first-in-human trial to evaluate a CAR-Treg cell therapy.
A study evaluating the efficacy and safety of vericiguat, a treatment for patients with worsening chronic heart failure, has met the primary efficacy endpoint.
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
A dengue fever vaccine candidate has demonstrated a high level of success in a Phase III trial, meeting its primary endpoints.
Over the last few years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Cory E Muraco and Wayne Way discuss current trends in biologics analysis.
Janssen has recently received marketing authorisation from the European Commission for Stelara to treat ulcerative colitis. Dr Jaime Oliver discusses the mode of action and why the treatment is needed.
A vote by an FDA committee has resulted in the suggestion that marketing authorisation is revoked for preterm birth treatment Makena.
A candidate TB vaccine’s efficacy level and acceptable safety profile have been confirmed in a three-year clinical trial.