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Geron finally brings a drug to market as FDA clears Rytelo

More than 30 years after it was first founded, Geron has claimed FDA approval for its first product – myelodysplastic syndromes (MDS) treatment Rytelo.

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First rare disease therapies chosen for FDA START programme

An initiative set up by the FDA to accelerate the development of therapies for rare disease in the same way that Operation Warp Speed delivered COVID-19 vaccine has chosen

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FDA panel votes against Lykos’ pioneer psychedelic therapy

FDA independent advisors have comprehensively voted against the use of Lykos Therapeutics’ therapy for post-traumatic stress disorder (PTSD) based on MDMA, also known as e

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Astellas refiles CLDN 18.2 cancer drug after FDA knockback

The US FDA has started a fresh review of Astellas' zolbetuximab, trying to become the first claudin (CLDN) 18.2-targeting drug to reach the US market, after turning it dow

R&D

parental permission, child assent, and consent in clinical trials

Parental permission, child assent, and adolescent autonomy i...

As a vulnerable population, children in general must rely on their parents or guardians to provide informed consent for them to participate in research.

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FDA competition seeks digital endpoints for Parkinson’s

The FDA is asking digital health technology developers to come up with a solution to measuring a common symptom of Parkinson’s disease that can have a serious impact on pa

Geron finally brings a drug to market as FDA clears Rytelo

First rare disease therapies chosen for FDA START programme

FDA panel votes against Lykos’ pioneer psychedelic therapy

Astellas refiles CLDN 18.2 cancer drug after FDA knockback

Parental permission, child assent, and adolescent autonomy i...

FDA competition seeks digital endpoints for Parkinson’s

Getting predictive technologies to patients, with Concr

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

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