(Corrects to clarify the total number of patients in the study in paragraph 10) May 27 (Reuters) - The U.S. Food and Drug ...

Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.

Replimune Group REPL-0.43%decrease; red down pointing triangle said Friday it has reached an agreement with the Food and Drug Administration on a path to resubmit its application for its experimental ...

Sanofi has received a priority review from the US Food and Drug Administration (FDA) for its new drug application (NDA) for venglustat, an oral glucosylceramide synthase inhibitor (GCSi) intended for ...

Replimune (REPL) stock surged after the company announced plans to resubmit a marketing application for its lead asset, RP1, in the U.S. Read more here.

The new wellness tool would alert users to signs of increasing blood pressure. Ōura is studying a separate feature to flag ...

The FDA has delayed a decision on the approval of AstraZeneca’s camizestrant, deferring its ruling to review analyses filed ...

"No tobacco product should look like candy—it’s a blatant ploy to target children and mask the true nature of these products, ...

Dr. Tracy Beth Høeg is leaving her role as head of the FDA division that regulates over-the-counter and prescription drugs, ...

Dr. Tracy Beth Høeg, leader of the Food and Drug Administration division responsible for regulating prescription and over-the ...

The FDA’s recent decision to withhold approval of a new skin cancer treatment fell like a hammer on doctors who treat ...