PTC Therapeutics Announces FDA Approval of AADC Deficiency …
WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved in the United States that is directly administered to the brain.
US FDA approves PTC Therapeutics' gene therapy for ultra-rare …
2 days ago · The U.S. Food and Drug Administration approved PTC Therapeutics' gene therapy to treat a potential fatal enzyme deficiency disorder, the company said on Wednesday, sending its shares up about 2% ...
PTC Therapeutics Announces FDA Approval of AADC Deficiency …
2 days ago · PTCT. --PTC Therapeutics, Inc. announced today the U.S. Food and Drug Administration accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy ...
FDA grants accelerated approval for PTC’s AADC deficiency gene …
1 day ago · PTCT. The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene therapy in the US that is directly delivered to the brain. This ...
PTC wins US approval of gene therapy for fatal enzyme disorder
1 day ago · PTC Therapeutics on Wednesday won Food and Drug Adminitration approval for Kebilidi, the first gene therapy cleared in the U.S. for direct administration to the brain. The treatment is designed for patients with aromatic L-amino acid decarboxylase, or AADC, deficiency, a condition that affects the way neurons transmit information to other cells.
PTC Therapeutics Announces FDA Acceptance and Priority …
3 days ago · WARREN, N.J., May 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza™ (eladocagene exuparvovec), a …
PTC Therapeutics Announces FDA Acceptance of Translarna™ …
WARREN, N.J., Oct. 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
FDA Approves First Gene Therapy for Treatment of Aromatic L …
2 days ago · The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric ...
FDA Grants Conditional Approval For PTC Therapeutics' Gene …
1 day ago · On Thursday, the FDA granted accelerated approval to PTC Therapeutics, Inc.’s (NASDAQ:PTCT) gene therapy for AADC deficiency, the first-ever gene therapy approved in the U.S. that is directly ...
PTC Therapeutics Announces FDA Approval of AADC Deficiency …
2 days ago · WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the ...
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