News MHRA's stature undermined by lack of resources says pharma The MHRA isn't sufficiently funded to meet its obligations and that could threaten UK investment in life sciences, according to an ABPI report.
News FDA kicks off review of Cytokinetics' aficamten for HCM Cytokinetics should hear back from the FDA next September about its application for Camzyos rival aficamten in obstructive hypertrophic cardiomyopathy
News Deadline looms for post-Brexit label changes for UK meds The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements.
News BMS files legal challenge to HHS' 340B rebate decision Bristol-Myers Squibb has become the latest pharma in the US to file a legal challenge to a block on a 340B drug rebate model opposed by HRSA.
News Sanofi opens $595m manufacturing facility in Singapore Sanofi has officially opened a modular biologics manufacturing facility in Singapore that is designed to allow rapid switching between products
News Kelun's MSD-partnered TROP2 drug gets first okay in China Kelun-Biotech has become the second drugmaker to bring a TROP2 ADC to regulatory approval, after its sac-TMT drug was cleared in China
News Ipsen' Bylvay fluffs its lines in biliary atresia trial Ipsen's IBAT inhibitor Bylvay has failed a trial in biliary atresia, a rare and serious liver disease that affects babies and has limited treatments.
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