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Regeneron Pharmaceuticals has said its COVID-19 antibody cocktail, REGEN-COV (casirivimab with imdevimab) reduced the risk of symptomatic infections by 81 percent in a late-stage trial. Read More
In a much-needed development, Johnson & Johnson began delivery of its one-shot COVID-19 vaccine within the EU yesterday as the trade bloc continues to clamor for enough doses to inoculate its 446 million residents. Read More
The FDA has selected Patrizia Cavazzoni as permanent director of the Center for Drug Evaluation and Research (CDER), a position previously held for many years by Acting Commissioner Janet Woodcock. Read More
The U.K.’s National Institute for Health and Care Excellence (NICE) has issued a preliminary rejection of Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) as a combination treatment for lung cancer in as-yet untreated patients. Read More
The FDA has issued a warning letter to About Mineral, an Orange, Ca-based company that sells Puriton, a direct-to-consumer line of topical skin products which it claims have been tested and are effective against COVID-19. Read More
The FDA has withdrawn five generic opioids from the U.S. market, after three sponsors failed to meet regulatory requirements for their abbreviated New Drug Applications (ANDAs). Read More
The FDA has found deficiencies in the biologics license application (BLA) data submitted for Provention Bio’s teplizumab, a monoclonal antibody being reviewed for delaying or preventing type 1 diabetes, and the agency’s evaluation of it is likely to be delayed as a result, the company said. Read More
In more bad news for AstraZeneca, the European Medicines Agency (EMA) announced that its safety committee is investigating reports of capillary leak syndrome, a rare, potentially life-threatening disorder, in individuals inoculated with the company’s COVID-19 vaccine. Read More