Skin cancer drug fast tracked under early access to medicines schemeA drug for advanced skin cancer, pembrolizumab, has become the first medicine to be fast tracked to patients under the UK’s early access to medicines scheme.…
US FDA approves antibiotic combination with new beta-lactamase inhibitor The US Food and Drug Administration has approved a new intravenous antibacterial product, Avycaz, which contains ceftazidime and a new beta-lactamase inhibitor, avibactam.…
FDA fast tracks approval of panobinostat for multiple myeloma The US Food and Drug Administration has fast-tracked the approval of the first histone deacetylase inhibitor to treat patients with multiple myeloma.…
Licensing deal will allow paediatric HIV drug to be used more widelyChildren with HIV in developing countries will now have access to generic paediatric formulations of raltegravir following a licence agreement with Merck.…
Breast cancer drug palbociclib gets expedited approval in United States The US Food and Drug Administration has approved palbociclib (Ibrance; Pfizer) for advanced (metastatic) breast cancer under its accelerated approval programme.…
New antibiotics for skin infections get seal of approval from European Medicines Agency Three new antibiotics to treat serious skin infections have been recommended for approval by the European Medicines Agency.…
EMA recommends suspending licences for 700 drugs over flawed analyses by GVK BiosciencesThe European Medicines Agency is recommending that the marketing authorisation be suspended for more than 700 generic products tested by GVK Biosciences.…
EMA recommends approval of liraglutide as weight loss drugThe European Medicines Agency is recommending that the prescription-only injectable drug liraglutide (Saxenda) should be granted a marketing authorisation as a weight loss product.…
Searching social networks to detect adverse reactions Regulators and pharmaceutical companies are monitoring social media posts for potential adverse drug reaction signals.…
Safinamide recommended for approval as Parkinson’s disease therapy A new medicine that allows Parkinson’s disease patients to spend more of the day symptom-free has been recommended for approval in Europe.…
