regulatory

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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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Applied Tx craters as FDA rejects lead product candidate

Applied Therapeutics plummets after the FDA turns down its marketing application for govorestat as a treatment for galactosaemia

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FDA probing cancer cases with Bluebird's CALD gene therapy

The FDA is scrutinising reports of haematological cancers in patients treated with bluebird bio's Skysona gene therapy for neurological disease CALD

Digital

Part 2 - Accelerating the Medical, Legal and regulatory (MLR...

Medical, legal, and regulatory review (MLR review) of promotional as well as non-promotional materials is one of the core responsibilities of medical and commercial teams within any life sc

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