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73,591 Results for "applied biosystems".
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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
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
Rapid Micro Biosystems to Participate in Upcoming March 2025 Investor Conferences
February 27, 2025
·
1 min read
Press Releases
Applied Therapeutics Reports Fourth Quarter and Year-end 2024 Financial Results
April 14, 2025
·
10 min read
Executive Appointments
After Month of Bad News, Applied Shuffles Leadership, Lays Out Uncertain Path for Rare Disease Drug
Following a 90% drop in share price due to an FDA rejection and a warning letter over Applied Therapeutics’ conduct during a clinical trial, the biotech’s CEO has stepped aside.
December 23, 2024
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2 min read
·
Annalee Armstrong
Press Releases
Agilent xCELLigence RTCA Instrumentation Applied in Recent FDA Approval
March 25, 2025
·
3 min read
Press Releases
Applied StemCell Announces Drug Master File Submission to the US FDA for their GMP-Grade iPSC Cell Line
April 14, 2025
·
2 min read
Press Releases
Applied Therapeutics Appoints Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer
March 19, 2025
·
4 min read
Genetown
T2 Biosystems Announces Commercial Expansion Through Hong Kong and Macau Distributor
T2 Biosystems, Inc., a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistant genes, announced the execution of a territory exclusive distribution agreement in Hong Kong and Macau.
June 25, 2024
·
4 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
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