If you’re considering getting an emotional support animal (ESA) or already have one, you’ll need to get an ESA letter as soon as possible. It’s an official letter that gives your animal recognized ...

Ensure operational excellence and the stability of ESA as an inclusive society.

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are resolvable FDA clinical reviews acknowledged that the clinical data are ...

Seeing Ms. Barry’s article demonstrated that this once unspoken and fraught subject has become more mainstream, that ...

I survived peritoneal mesothelioma thanks to the love, prayers, and support of family, friends, and strangers who reminded me ...

In other recent news, Ultragenyx Pharmaceutical Inc. has faced a regulatory setback as the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for its gene therapy UX111 ...

Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA) ...

Company News Published 07/11/2025, 04:36 PM 0 FDA issues complete response letter for Ultragenyx’s MPS IIIA therapy RARE 1.58% ...

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are resolvable FDA clinical reviews acknowledged that the clinical data are robust ...

Investing.com -- Ultragenyx Pharmaceutical (TADAWUL: 2070) Inc. (NASDAQ: RARE) stock fell over 5% after the company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete ...

FDA cites trial design concerns in Complete Response Letter (CRL) to Replimune: The agency rejected the RP1 Biologics License Application (BLA) due to issues with the IGNYTE trial’s control and ...