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In a 13-10 vote yesterday, an FDA advisory committee recommended that the FDA should grant Emergency Use Authorization (EUA) for molnupiravir, the antiviral pill co-developed by Merck and Ridgeback Biotherapeutics. Read More
With government funding set to expire on Friday, the House could vote as soon as today on a stopgap measure to avert a shutdown and keep federal agencies operating. Read More
GlaxoSmithKline (GSK), whose COVID-19 vaccine development efforts have lagged behind those of competitors, has hired away one of the top scientists behind the Pfizer COVID-19 jab, which has been the most ubiquitous of the three vaccines approved for use in the U.S. Read More
Amid the increasing travel bans, cancelations and worry caused by the new Omicron variant of the SARS-CoV-2 virus, Acting FDA Commissioner Janet Woodcock said yesterday that the FDA is ready to quickly collaborate with industry in whatever way is needed. However, immunogenicity studies would be required if vaccine makers need to modify their vaccines. Read More
Armed with strong results from a late-stage clinical trial, ImmunoGen plans to submit a new Biologics License Application (BLA) for its drug/antibody conjugate Mirvetuximab (mirvetuximab soravtansine) as a treatment for women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Roche’s Avastin (bevacizumab). Read More
Attorneys for two Ohio counties said the overdose deaths, overwhelmed courts, social services agencies and law enforcement cost each of the counties approximately $1 billion. Read More