regulatory

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Alnylam's Onpattro clears FDA vote for ATTR-cardiomyopathy

Despite a sceptical appraisal by FDA reviewers, Alnylam's Onpattro has been recommended for approval as a treatment for transthyretin amyloidosis cardiomyopathy (ATTR-CM)

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EU clears review of Xtandi in earlier-stage prostate cancer

The EMA will kick off a review of Astellas and Pfizer's prostate cancer therapy Xtandi in an earlier-stage form of the cancer, which if approved could give the product a l

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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

Alnylam's Onpattro clears FDA vote for ATTR-cardiomyopathy

EU clears review of Xtandi in earlier-stage prostate cancer

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

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