Seeking Alpha

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

NOVATO, Calif., July 11, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (RARE), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) ...
Morningstar

Corcept Therapeutics (CORT) Faces Investor Scrutiny Amid Receipt of FDA Complete Response Letter For Relacorilant, Shares Tank 50% - Hagens Berman

SAN FRANCISCO, Jan. 6, 2026 /PRNewswire/ -- Investors in Corcept Therapeutics Incorporated (NASDAQ: CORT) saw the price of their shares crater 50% on December 31, 2025 after the company announced its ...
Seeking Alpha

PIERRE FABRE PHARMACEUTICALS STATEMENT REGARDING RECEIPT OF COMPLETE RESPONSE LETTER FOR TABELECLEUCEL BIOLOGICS LICENSE APPLICATION FROM THE U.S ...

SECAUCUS, N.J., Jan. 12, 2026 /PRNewswire/ -- On January 9, 2026, Pierre Fabre Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) stating ...
Monthly Prescribing Reference

FDA Denies Approval of Dichloroacetate for Rare Mitochondrial Disorder

The Company is currently seeking a path forward with the FDA that would not require an additional clinical trial. The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to ...
Healio

FDA issues complete response letter to Aquestive for Anaphylm sublingual epinephrine

Please provide your email address to receive an email when new articles are posted on . The FDA was not concerned about the drug’s pharmacokinetics. Concerns included packaging, patient use and ...