regulatory

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CStone gets a win for sugemalimab in oesophageal cancer

Suzhou-based CStone Pharmaceuticals' checkpoint inhibitor sugemalimab has proved effective in a trial as a first-line therapy for oesophageal cancer, setting up a regulatory filing in China

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FDA "collaborated" with Biogen on Aduhelm approval, says inq...

The FDA's interactions with Biogen in the build-up to last year's controversial approval of Alzheimer's disease therapy Aduhelm have been described as "inappropriate" and "atypical" in a co

Market Access

Upholding regulatory compliance in decentralised trials

Before getting lost in the vast options a decentralised clinical trial (DCT) setup provides, sponsors considering a DCT model need to keep in mind that it is not a one-size-fits-all approac

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Idorsia files resistant hypertension drug aprocitentan in US

Switzerland's Idorsia has submitted a new drug application to the FDA for aprocitentan as a treatment for people whose blood pressure remains stubbornly high despite treatment and who are a

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Second phase 3 trial extends Astellas' lead in claudin 18.2 ...

Astellas has confirmed it is out in front among developers of drugs targeting claudin 18.2, after a second phase 3 trial of zolbetuximab hit its objectives.

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FDA adcomm votes down Cytokinetics heart failure drug

An FDA advisory committee has voted against approval of Cytokinetics' cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough.

CStone gets a win for sugemalimab in oesophageal cancer

FDA "collaborated" with Biogen on Aduhelm approval, says inq...

Upholding regulatory compliance in decentralised trials

Idorsia files resistant hypertension drug aprocitentan in US

Second phase 3 trial extends Astellas' lead in claudin 18.2 ...

FDA adcomm votes down Cytokinetics heart failure drug

Ipsen' Bylvay fluffs its lines in biliary atresia trial

Discover a new era of healthcare panel engagement: Grounded ...

regulatory

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