News FDA seeks changes to GLP-1, flu shot labels The FDA has asked manufacturers of GLP-1 drugs used for weight loss to remove warnings of suicidal thinking, but added warnings to flu shots.
News Sentynl gets first FDA approval for rare disease Menkes Children with a devastating, rare disorder of copper metabolism, called Menkes disease, now have an FDA-approved treatment for the first time.
News AbbVie turbocharges its US investment promise to $100bn AbbVie finally agrees a Most-Favoured Nation pricing deal with the US administration, with a $100 billion investment promise attached.
News FDA removes barriers to cell, gene therapy development FDA wants to exert regulatory flexibility on cell and gene therapies in an effort to bring them to patients more quickly and efficiently.
News J&J jumps on the MFN pricing train Johnson & Johnson is the latest pharma group to agree a Most-Favoured Nation (MFN) drug pricing deal with the Trump administration to avert tariffs.
News FDA turns down Hetlioz for jet lag once again Vanda will continue to push for approval of Hetlioz for jet lag, despite the FDA saying its trial designs were not satisfactory.
News Ultragenyx to slash costs after Angelman trial failure Ultragenyx's therapy for the rare genetic disorder Angelman syndrome, apazunersen, has flunked a late-stage trial, crashing its share price.
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