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The monoclonal antibodies that have shown efficacy against Omicron are Gilead Sciences’ Veklury (remdesivir) and GlaxoSmithKline’s and Vir Biotechnology’s Xevudy (sotrovimab). Read More
The FDA has issued draft guidance clarifying the regulatory requirements for collecting and providing portions of official samples of drugs, foods or cosmetics that may be needed for the agency’s analysis or any litigation involving the items. Read More
Pfizer is coming under increasing pressure to make its highly effective COVID-19 antiviral treatment Paxlovid more accessible to countries beyond those in North America and Europe. Read More
The FDA has slapped Eli Lilly with an Untitled Letter over what it calls a “misleading” and “particularly concerning” ad the company posted on Instagram for its type 2 diabetes drug Trulicity. Read More
The FDA has released draft guidance for applicants and holders of an abbreviated new drug application (ANDA) on updating their labeling after revisions to the approved labeling of a reference listed drug (RLD) on which a generic drug is based. Read More
Both studies are in line with real-world data released by the Centers for Disease Control and Prevention last week showing that a third dose of vaccine from Pfizer/BioNTech or Moderna slashed Omicron-related COVID-19 hospitalizations by 90 percent. Read More
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