On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general ...

Summit Therapeutics (NASDAQ:SMMT) is one of the best large cap stocks under $100 with huge upside potential. On January 14, H ...

The U.S. Food and Drug Administration ("FDA") recently issued updated final guidance documents on general wellness products and clinical ...

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

When trial participants aren't representative, the evidence for universally adopted cancer treatment guidelines is incomplete ...

Traditional clinical trial data are pseudonymized data, and these data may not contain information on a patient that directly identifies them, like a name, address, or phone number. However, ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

The newly established CAB has been formed to provide independent clinical and scientific guidance as the Company progresses PSX-001 into its next phase of clinical and regulatory development. The CAB ...

“This usability study is a key milestone in advancing NASARIX™ toward clinical trials, which are expected to commence in Q3 2026,” said Tomer Izraeli, CEO of Polyrizon. “It underscores our commitment ...

The FDA has granted priority review to the new drug application (NDA) for gedatolisib, a first-in-class multi-target ...

By Patrick Wingrove Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the ...