The US Food and Drug Administration (FDA) has rejected a new indication for Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) saying that more data is required. The proposed indication is for BRAF V600 positive metastatic melanoma.
The first monoclonal antibody for multiple myeloma has been approved by the US Food and Drug Administration under its accelerated approval procedure. Darzalex (daratumumab), was developed by Genmab A/S and licensed to Janssen Biotech Inc in 2012.
Guido Rasi has been appointed to a new five-year term as executive director of the European Medicines Agency following a fresh recruitment process. Prof Rasi had been forced to step down a year ago in the wake of a procedural challenge to his earlier appointment.
A new lung cancer drug developed by AstraZeneca Plc and a diagnostic developed by Roche have been approved by the US Food and Drug Administration to identify and treat patients with non-small cell lung cancer whose tumours have a specific gene mutation.
The US Food and Drug Administration has expanded the approved uses for Harvoni (ledipasvir and sofosbuvir), a combination pill for chronic hepatitis C (HCV), to include patients co-infected with HIV as well as those with genotype 4, 5 and 6 infections.
The US Food and Drug Administration has approved a new combination therapy for advanced melanoma and has advised physicians to test for certain genetic mutations before prescribing the drugs. Both treatments are marketed by Genentech (Roche).
The US Food and Drug Administration has approved a new combination therapy for patients infected with HIV-1 that contains a new form of tenofovir, an antiretroviral medicine already use in other HIV combination treatments.
A new treatment for melanoma, which is based on a genetically engineered virus, has received a positive opinion from the European Medicine Agency – the first step towards marketing authorisation in Europe.
A new therapy for advanced pancreatic cancer, one of the most difficult-to-treat diseases, has been approved by the US Food and Drug Administration. The combination therapy has been approved for patients who have previously received gemcitabine.
A new coagulation factor replacement therapy has been approved in the US for patients with hereditary Factor X deficiency, a condition that is characterised by the failure of the blood to clot normally.