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The biosimilars market has had a plodding start in the U.S., but the products are finally picking up momentum, IQVIA reported, citing three examples of new products with strong potential. Read More
The price of dexamethasone, now in demand as a COVID-19 treatment, has increased dramatically in recent months and is poised to go up, the research group 46Brooklyn said. Read More
The FDA issued a warning letter to LEC Custom Products, an over-the-counter drugmaker in Ontario, Canada for serious violations of current good manufacturing practices. Read More
Yet another cancer indication may be in sight for Bristol-Myers Squibb’s blockbuster drug Opdivo (nivolumab) based on the latest results from a phase 3 clinical trial. Read More
Dozens of medical experts from across the nation have written a letter to FDA Commissioner Stephen Hahn, Center for Biologics Evaluation and Research (CBER) Director Peter Marks and the FDA’s vaccine advisory committee calling for stronger requirements for monitoring participants in COVID-19 vaccine trials. Read More
Eli Lilly has submitted a request for an Emergency Use Authorization (EUA) for its monoclonal antibody LY-CoV555, following new positive trial data for its antibody combo in treating COVID-19. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP), which has only issued a handful of warning letters so far this year, sent out two on the same day to drugmakers in South Carolina and New Jersey. Read More
The FDA is calling for AMAG Pharmaceuticals to withdraw its preterm birth injection Makena (hydroxyprogesterone caproate), as well as its generics, from the market after a postmarket study failed to demonstrate efficacy. Read More
The HIV-1 antiviral drug combination lopinavir-ritonavir, marketed by AbbVie under the brand name Kaletra, has shown no benefit in reducing all-cause mortality among patients hospitalized with COVID-19 in the UK’s RECOVERY trial. Read More