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514,318 Results for "applied genetic technologies corporation".
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Complete response letters
Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.
December 2, 2024
·
3 min read
·
Tristan Manalac
BioMidwest
Applied Genetic Technologies Corporation Urges Shareholders to Tender Their Shares by November 28, 2022
Applied Genetic Technologies Corporation, President and Chief Executive Officer, Sue Washer, sent the following letter to stockholders.
November 14, 2022
·
5 min read
Press Releases
PacBio Technology Powers Landmark Multiomic Study Published in Nature Genetics
January 30, 2025
·
5 min read
BioMidwest
Applied Genetic Technologies Corporation Reminds Shareholders to Tender Their Shares by November 28, 2022
Applied Genetic Technologies Corporation, President and Chief Executive Officer, Sue Washer, sent the following letter to shareholders:
November 3, 2022
·
6 min read
Press Releases
Applied DNA’s LineaRx Subsidiary Stands Ready to Support the Reshoring of Drug Development and Manufacturing with U.S.-Produced Synthetic DNA
April 22, 2025
·
4 min read
Gene therapy
Regeneron’s Gene Therapy Restores Hearing in Patients with Rare Genetic Condition
The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.
February 24, 2025
·
4 min read
·
Dan Samorodnitsky
Press Releases
Myriad Genetics Issues Quality, Innovation, and Corporate Responsibility Report
January 7, 2025
·
3 min read
Regulatory
FDA Warns Applied Therapeutics of ‘Objectionable Conditions’ in Govorestat Study
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.
December 4, 2024
·
2 min read
·
Tristan Manalac
Press Releases
Healthcare Integrated Technologies Inc. Announces Corporate Name Change to SafeSpace Global Corporation and Ticker Symbol Update
April 24, 2025
·
2 min read
Press Releases
Applied DNA Announces Fourth Quarter and Fiscal Year 2024 Financial Results, Announces Strategic Restructuring to Prioritize the Manufacture of Critical Starting Materials for Genetic Medicines
December 17, 2024
·
15 min read
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