(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.

Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and a leader in cholesterol trafficking biology and ...

Many telehealth companies have emerged in recent years offering easy access to GLP-1 weight loss drugs as demand has exploded ...

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 ...

According to the department, the Hepcludex injection is the first treatment for hepatitis delta virus (HDV) in adults lacking cirrhosis or with compensated cirrhosis. “Today’s approval fills a ...

Third FDA Orphan Drug Designation Continues to Advance RenovoRx's Therapeutic Oncology Pipeline and Provides Seven Years of Market ExclusivityMOUNTAIN VIEW, Calif., May 28, 2026 (GLOBE NEWSWIRE) -- ...

CVS Caremark will start covering Eli Lilly's Foundayo and resume covering its Zepbound obesity drugs in the next several ...

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.

CVS Health will reinstate coverage of Eli Lilly's weight-loss injectable Zepbound and begin coverage of the anti-obesity pill ...

Organizational changes and layoffs that began in 2025 make me worry that the agency will struggle to fulfill its crucial mission ...