News Are RSV shots next in line for restrictions in the US? After pushing for restrictions on vaccines for COVID-19 and hepatitis B, the Trump administration seems to be turning its attention to RSV shots.
News FDA clears first gene therapy for rare genetic disease WAS Fondazione Telethon's Waskyra has become the first gene therapy in the US for Wiskott-Aldrich syndrome, and the first taken to market by a non-profit.
News UK confirms lower clawback rate for NHS medicines The UK has cut its voluntary rebate rate for new medicines supplied to the NHS to 14.5% next year, but industry says this is "only the first step."
News Antibiotic is first approval in FDA national priority scheme FDA approves its first 'national priority' drug – a version of the widely used antibiotic Augmentin XR – in double-quick time.
News ASH: FDA okays Gamida aplastic anaemia therapy as data drops The first cell therapy for severe aplastic anaemia – Gamida Cell's Omisirge – has been approved by the FDA.
News FDA reveals real-world pilot for digital health tools The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies for chronic diseases to market more quickly.
News Pharvaris plans filings for HAE drug after pivotal trial win Pharvaris has reported positive data from a phase 3 trial of its drug for preventing HAE attacks, setting up marketing applications next year.
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