News CBER chief Vinay Prasad to leave FDA once again For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.
News FDA ramps up its pushback against compounded GLP-1s In a move that will please Novo Nordisk and Eli Lilly, the FDA sent warnings to 30 telehealth firms, accusing them of illegally marketing GLP-1 drugs.
News CMS extends deadline for MFN pricing pilot scheme CMS has extended the deadline for its Medicaid drug pricing pilot, GENEROUS, to "provide interested drug manufacturers more opportunity to join."
News US lawmakers take FDA to task over rare diseases record Lawmakers and patient advocates in the US are concerned that the FDA's regulation of rare disease therapies has been inconsistent and overly cautious.
News In brief SOTU remarks, Trump asks Congress to "codify" MFN In a speech at least nominally focused on the economy and affordability, President Trump put surprisingly little emphasis on his drug pricing efforts.
News FDA maps new regulatory route for ultra-rare diseases The FDA has sketched out its 'plausible mechanism' regulatory pathway for individualised therapies that treat ultra-rare diseases.
News Novo sues Lilly over 'misleading' GLP-1 ad campaigning The rivalry between Novo Nordisk and Eli Lilly in the GLP-1 market has spilled over into the courts in the US, with claims of misleading advertising.
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