The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...

FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, ...

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...

With the FDA quietly rolling back DEI initiatives under Trump’s latest executive order, experts warn that underrepresentation ...

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...

Pharmaceutical giant GlaxoSmithKline (GSK) has lifted its long-term sales guidance as it hailed a strong drug pipeline.

On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...

The FDA says the cybersecurity vulnerabilities identified may put patients at risk when the device is connected to the ...

Neurocrine's pipeline includes 12 clinical programs, with two Phase 3 trials due to report in 2025. See why I rate NBIX stock ...

Tectonic Therapeutic has done well to advance its Fc-fusion protein candidate TX45 into a phase 2 study targeting patients ...