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As Novavax gears up to put its investigational COVID-19 vaccine through a phase 3 U.S. trial this month, the FDA has granted the candidate a Fast-Track designation in order to speed up its regulatory review process. Read More
Pfizer and BioNTech have pulled ahead to become the frontrunners in the race for a COVID-19 vaccine, announcing that the first interim analysis from their late-stage trial showed the candidate was more than 90 percent effective. Read More
An FDA inspection of Romark Global Pharma’s Manati, Puerto Rico drug manufacturing facility revealed problems with contamination of drug products and equipment. Read More
The FDA has published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Read More
One arm of the UK’s RECOVERY trial evaluating potential COVID-19 treatments is including aspirin in combination with the drugs being evaluated. Read More
Humanigen on Friday revealed positive interim data in a late-stage clinical trial of its monoclonal antibody lenzilumab for the treatment of COVID-19 patients, but a trial design expert contended that the disclosure was inappropriate and could put the trial’s integrity at risk. Read More
Biogen and the FDA failed to convince an advisory committee in a crucial meeting Friday that the company’s potential blockbuster Alzheimer’s drug aducanumab has shown enough evidence of effectiveness. Read More