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Sanofi is partnering with Protas, a new UK-based nonprofit organization masterminded by Martin Landray, the leader of the UK’s lauded and highly successful RECOVERY trial, which evaluated multiple treatments for COVID-19. Read More
Pfizer and OPKO Health drew a Complete Response Letter (CRL) from the FDA for their Biologics License Application (BLA) for Ngenla (somatrogon), an injectable, long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Read More
As the Omicron variant continues to spread rapidly, the FDA has granted accelerated approval to Gilead Sciences for Veklury (remdesivir), the first FDA-approved COVID-19 treatment for patients outside hospitals who are at high risk of progression to severe COVID-19. Read More
“Giving foreign drug manufacturers in countries like China a ‘heads up’ before facility inspections … makes about as much sense as relying on the [Chinese Communist Party] to make these critical goods in the first place,” said Sen. Joni Ernst (R-Iowa). Read More
Kura Oncology said Friday that the FDA has lifted a partial clinical hold placed on the company’s early-stage clinical trial of its drug candidate, KO-539, in patients with relapsed or refractory acute myeloid leukemia (AML). Read More
The UK’s National Institute for Health and Care Excellence (NICE), the body that evaluates medicines for use by the National Health Service (NHS), is changing the way it makes judgments on treatments. Read More