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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
A Moderna or Pfizer/BioNTech COVID-19 booster dose was found to give highly effective protection against the Delta and Omicron variants, the Centers of Disease Control and Prevention (CDC) said Friday. Read More
Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through fiscal year 2020 to fiscal year 2021, according to the latest data posted on the agency’s “dashboard” — which tracks how well the agency is living up to its review commitments under the user fee programs. Read More