News CHMP backs first drug for lung disease bronchiectasis Insmed gets EU recommendation for first non-cystic fibrosis bronchiectasis therapy Brinsupri, plus other CHMP decisions.
News FDA hands out first national priority vouchers to nine firms The FDA has named the first products to take advantage of its recently announced Commissioner's national priority voucher programme.
News UK and US agencies team up for medtech, AI regulation The regulatory authorities in the UK and US have agreed to work more closely together on the regulation of medical technologies and AI.
Oncology Advancing radiopharmaceutical development: Preclinical preci... Radiopharmaceutical development must move beyond fixed paradigms toward patient-specific, data-driven optimisation.
News FDA pilots fast-track scheme for US-made generics In another effort to boost domestic drug manufacturing, the FDA is piloting fast-track reviews for generics tested and made in US facilities.
News Rocket aborts FDA filing for Fanconi gene therapy Rocket Pharma has withdrawn a filing in the US for its experimental gene therapy for Fanconi anaemia, but may consider partnering the programme.
News Repligen builds in cell therapy with $1.5bn BioLife takeover Repligen has reached a deal to buy cell therapy specialist BioLife Solutions for $1.5bn, tapping into a market growing at breakneck speed.
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