In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...
The practice of “sunscreen doping” has emerged as a workaround to the FDA’s burdensome regulations for sunscreen ingredients, ...
For too long, the promise of personalized therapies has been tantalizingly close, yet frustratingly out of reach for ...
The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete ...
The Food and Drug Administration has declined to review Moderna’s application for the first mRNA-based flu vaccine, a decision that shocked the company and that comes as the agency plans to tighten ...
Regulatory emphasis shifts from ORR and response duration to MRD negativity and CR as surrogate endpoints intended to shorten development timelines by capturing deeper molecular responses. MRD ...
WASHINGTON (AP) — A Democratic lawmaker raised new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs, including whether senior officials ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
In its feedback, the FDA acknowledged the potential breast cancer risk associated with T use in women—a central safety issue that has historically limited the development of a T therapy for women.
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