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NICE backs first disease-modifying drug for ARG1 deficiency

Immedica's Loargys is poised to become the first NHS therapy for ultra-rare genetic disorder ARG1 deficiency that can alter the course of the disease.

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EU approval for new asthma drug Exdensur lifts GSK

EU approval takes GSK a step closer to fulfilling its blockbuster sales hopes for new long-acting respiratory drug Exdensur.

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UK seeks views on indefinite CE marks for medical devices

The UK has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in GB should be recognised indefinitely.

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FDA turns down 'national priority' drug from Disc Medicine

One of the beneficiaries of the FDA's national priority vouchers, Disc Medicine, has had its marketing application turned down by the regulator.

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Report says Jim O'Neill's time at HHS is nearing its end

HHS Deputy Secretary Jim O'Neill – who is also head of the CDC – is said to be on the way out after a reshuffle of department leadership by RFK Jr.

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PTC pulls file for Duchenne therapy on FDA feedback

PTC Therapeutics has abandoned its latest attempt to secure FDA approval for Duchenne muscular dystrophy treatment Translarna.

NICE backs first disease-modifying drug for ARG1 deficiency

EU approval for new asthma drug Exdensur lifts GSK

UK seeks views on indefinite CE marks for medical devices

FDA turns down 'national priority' drug from Disc Medicine

Report says Jim O'Neill's time at HHS is nearing its end

PTC pulls file for Duchenne therapy on FDA feedback

Recordati gets €10.9bn takeover bid from private equity firm

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