US FDA declines to approve Applied Therapeutics' genetic disease drug
22 小时之前 · Nov 27 (Reuters) - Applied Therapeutics , opens new tab said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic metabolic disease, casting a cloud ...
Wait for galactosemia therapy goes on after FDA shuns Applied ...
9 小时之前 · The US Food and Drug Administration (FDA) has declined to approve Applied Therapeutics’ govorestat for classic galactosemia, prolonging the wait for the first marketed treatment for the genetic disease.. US-based Applied Therapeutics had been hoping its central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI) would become the first pharmacological treatment for the disease.
Applied Therapeutics: FDA Denial Of Govorestat NDA As …
5 小时之前 · Applied Therapeutics is reviewing the feedback from the FDA and plans to immediately request a meeting to discuss requirements for a potential resubmission of the NDA or appeal of the decision ...
Applied Therapeutics’ NDA for govorestat receives negative …
19 小时之前 · Applied Therapeutics is reviewing the feedback from the FDA and plans to immediately request a meeting to discuss requirements for a potential resubmission of the NDA or appeal of the decision ...
Applied Therapeutics Receives Complete Response Letter from U.S. FDA ...
22 小时之前 · Applied Therapeutics is reviewing the feedback from the FDA and plans to immediately request a meeting to discuss requirements for a potential resubmission of the NDA or appeal of the decision ...
Applied Therapeutics: FDA Issues CRL For New Drug Application …
11 小时之前 · (RTTNews) - Applied Therapeutics (APLT) announced the FDA has issued a Complete Response Letter for the New Drug Application for govorestat, for the treatment of Classic Galactosemia.
Applied Therapeutics Receives Complete Response Letter from U.S. FDA ...
22 小时之前 · NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose ...
Applied Therapeutics Provides Regulatory Update on Govorestat …
2024年9月18日 · Govorestat has also received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Galactosemia, PMM2-CDG, and SORD Deficiency; Pediatric Rare Disease designation for Galactosemia and PMM2-CDG; and Fast Track designation for Galactosemia.
Applied Therapeutics Announces FDA Acceptance and Priority …
NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing ...
Applied Therapeutics Receives FDA Complete Response Letter …
1 天前 · Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical ...