clinical trials

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Makary says FDA will "end two-trial dogma" for approvals

The FDA plans to adopt a new policy that will do away with the default requirement to base regulatory filings for new medicines on two pivotal trials.

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Novartis' oral BTK drug moves the needle in CINDU

Novartis is set to expand the label for its oral BTK inhibitor Rhapsido, keeping the drug on course to become one of its biggest-ever brands.

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Compass points to strong psilocybin data in depression

Armed with new data, Compass wants to talk to the FDA about filing its psilocybin therapy COMP360 for approval in treatment-resistant depression.

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Helus' psychedelic drug DMT 'could help treat depression'

Helus' psychedelic derived from ayahuasca, a brew used in shamanistic rituals in South America, has shown promise as a treatment for depression.

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Roche trial offers hope to patients with rare kidney disease

A study of Roche's Gazyva has raised the prospect of a first approved therapy for the rare kidney disorder primary membranous nephropathy.

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Bankruptcy threat looms as Quince runs out of options

Investor panic has poleaxed Quince Therapeutics share price, after a regulatory filing revealed the biotech's cash is running out.

Makary says FDA will "end two-trial dogma" for approvals

Novartis' oral BTK drug moves the needle in CINDU

Compass points to strong psilocybin data in depression

Helus' psychedelic drug DMT 'could help treat depression'

Roche trial offers hope to patients with rare kidney disease

Bankruptcy threat looms as Quince runs out of options

FDA points to liver injury with Amgen's Tavneos

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clinical trials

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