regulatory

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FDA blocks new use for AstraZeneca's Ultomiris

AstraZeneca has been successful at rolling out its long-acting complement C5 inhibitor Ultomiris in the uses approved for its predecessor Soliris – until now, that is.

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EMA starts review of Italfarmaco's Duchenne drug

Italfarmaco's marketing application for HDAC inhibitor givinostat as a treatment for Duchenne muscular dystrophy (DMD) has been accepted by the EMA, setting up an approval

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FTC hold raises hope of Amgen/Horizon deal progress

The Federal Trade Commission (FTC) in the US has paused its legal challenge to Amgen's proposed acquisition of Horizon Therapeutics, setting up settlement talks that may g

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Pharma incensed by EU's compulsory licensing proposal

Pharma industry bodies have slammed a proposal by the European Commission to set up a compulsory licensing (CL) framework for medicines in emergency situations, claiming t

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Celadon gets nod to start cannabis trial for pain in UK

Celadon Pharmaceuticals has secured the final approval needed to start a large-scale trial of its cannabinoid therapy for chronic pain in the UK.

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FDA rejects Citius' revived IL-2 therapy for lymphoma

The FDA has rejected Citius Pharmaceuticals' marketing application for Lymphir, an updated version of a lymphoma therapy withdrawn from sale several years ago.

FDA blocks new use for AstraZeneca's Ultomiris

EMA starts review of Italfarmaco's Duchenne drug

FTC hold raises hope of Amgen/Horizon deal progress

Pharma incensed by EU's compulsory licensing proposal

Celadon gets nod to start cannabis trial for pain in UK

FDA rejects Citius' revived IL-2 therapy for lymphoma

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