FDA releases a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency had repeatedly warned the company against submitting its NDA for relacorilant.
Ultragenyx Pharmaceutical resubmits a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A.
FDA releases a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency had repeatedly warned the company against submitting its NDA for relacorilant.
Ultragenyx Pharmaceutical resubmits a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A.
Elevar Therapeutics files an NDA for lirafugratinib as a second-line treatment for patients with cholangiocarcinoma whose tumors harbor FGFR2 fusions or rearrangements.
Sen. Rick Scott (R-FL) introduces legislation that would require prescription drug labels in the U.S. to disclose where drugs and their active pharmaceutical ingredients are manufactured.
