News FDA prior knowledge guide seeks to speed cell, gene therapy The FDA has laid out a framework to use 'prior knowledge' on manufacturing, non-clinical, and clinical data to support cell and gene therapy filings.
News SCOTUS won't hear pharma's IRA complaints The US Supreme Court has refused to consider lawsuits from pharma groups challenging Medicare's drug pricing negotiation powers.
News After refusing to resign, CDER head Høeg is fired The turmoil at the FDA continues with the news that Tracy Beth Høeg has been fired as acting head of CDER, to be replaced by Michael Davis.
News SCOTUS retains telemedicine access to abortion pill The Supreme Court of the US has ruled that abortion pill mifepristone can continue to be prescribed remotely and delivered by mail-order – for now.
News Is Makary on the way out, and who might replace him? Marty Makary's position as FDA Commissioner is said to be in jeopardy, raising the threat of further chaos at the agency if he is ousted.
News Danco fights back after US court curbs abortion pill access In another setback for abortion care in the US, an appeals court has issued an order restricting the distribution of mifepristone through the mail.
News Moderna jab on trial for cancer-causing syndrome Patients with Lynch syndrome could have a potential treatment on the horizon, as a Moderna mRNA vaccine starts trials at Oxford University.
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