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Warning letter adds to Applied Tx run of bad news

Applied Therapeutics gets a warning letter from the FDA over a trial of rare disease drug govorestat, which was rejected by the agency last week.

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Cytokinetics' president and chief executive Robert Blum

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

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'UK Only' red stamp on manufacturing facility

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.

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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.

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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

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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

Warning letter adds to Applied Tx run of bad news

FDA kicks off review of Cytokinetics' aficamten for HCM

Deadline looms for post-Brexit label changes for UK meds

BMS files legal challenge to HHS' 340B rebate decision

Sanofi opens $595m manufacturing facility in Singapore

Kelun's MSD-partnered TROP2 drug gets first okay in China

Amgen's Imdelltra scores again in small cell lung cancer

Discover a new era of healthcare panel engagement: Grounded ...

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