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Sanofi extends its Pompe range with first Nexviazyme OK

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder.

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Lilly sets out its stall on donanemab as filing approaches

The FDA's approval of Biogen's Aduhelm for Alzheimer's disease has emboldened Eli Lilly to move forward plans to file its own candidate donanemab later this year, although it acknowledges i

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Failed trial nixes another FDA approval, this time for BMS' ...

Bristol-Myers Squibb's HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed

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Novartis cleared to restart trials of new Zolgensma delivery...

The FDA has relaxed a clinical hold on clinical trials of Novartis' intrathecal formulation of spinal muscular atrophy (SMA) gene therapy Zolgensma, allowing a new phase 3 trial to get unde

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Abbott bags FDA okay for AI-based heart imaging software

The FDA has approved an artificial intelligence-based imaging software developed by Abbott that is used to help physicians carry out procedures like implanting stents to open up narrowed bl

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FDA gives breakthrough status to Biofourmis' heart failure D...

A digital therapeutic for patients with heart failure has been awarded breakthrough device status by the FDA – said by its developer Biofourmis to be the first time the US regulator h

Sanofi extends its Pompe range with first Nexviazyme OK

Lilly sets out its stall on donanemab as filing approaches

Failed trial nixes another FDA approval, this time for BMS' ...

Novartis cleared to restart trials of new Zolgensma delivery...

Abbott bags FDA okay for AI-based heart imaging software

FDA gives breakthrough status to Biofourmis' heart failure D...

Third Rock in $2bn drug-hunting pact with China's Funnel

Securing your ROI: Turning post-acquisition integration into...

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