EMA recommends approval of antibiotic combination to treat multi-drug resistant bacteria A new combination antibacterial drug is being recommended for approval across the European Union (EU).…
EMA review confirms pneumonia risk linked to inhaled corticosteroids A medicines safety review has confirmed a risk of pneumonia triggered by inhaled corticosteroids in patients with chronic obstructive pulmonary disease but was unable to specify whether there are any differences in risk for different products.…
Combination drug approved in Europe for metastatic colorectal cancer A new combination oral treatment, Lonsurf, has been granted a marketing authorisation for adults with metastatic colorectal cancer by the European Commission.…
EMA extends review of antivirals for hepatitis C The European Medicines Agency is extending its review of direct-acting antiviral treatments for hepatitis C to look at evidence that shows they are associated with liver cancer recurrence.…
Migalastat set for approval as first oral therapy for Fabry disease The European Medicines Agency has recommended the approval of migalastat for the treatment of the rare genetic disorder Fabry disease.…
Gene therapy for ‘bubble boy’ syndrome on track for EU approval Children with an extremely rare immune deficiency disease are set to have access to gene therapy, following a recommendation for approval by the European Medicines Agency.…
EMA recommends conditional approval of daratumumab The European Medicines Agency has recommended the multiple myeloma treatment daratumumab for conditional marketing authorisation.…
EMA to review safety of direct-acting antivirals after reports of hepatitis B reactivation The European Medicines Agency is to review the safety of direct-acting antivirals used to treat patients with chronic hepatitis C infection.…
Review finds benefits of corticosteroids outweighs pneumonia risk in COPD The risk of pneumonia associated with the use of inhaled corticosteroids by patients with chronic obstructive pulmonary disease is outweighed by the benefits of treatment, according to the findings of a safety review by the European Medicines Agency.…
EMA reviews safety of blood cancer drug idelalisib The European Medicines Agency has launched a safety review of blood cancer drug idelalisib (Zydelig) after data from three clinical trials suggested an increased risk of death associated with the drug.…