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71,313 Results for "applied biocode".
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Press Releases
Applied BioCode Announces New Nucleic Acid Extraction Claim for KingFisher™ Flex Nucleic Acid Purification System with BioCode® Gastrointestinal Pathogen Panel (GPP)
January 15, 2025
·
4 min read
Business
Applied BioCode Announces Retirement of CEO Chris Bernard
Applied BioCode announced the retirement of Chris Bernard as Chief Executive Officer.
March 21, 2024
·
3 min read
Biotech Beach
Applied BioCode Announces the Launch of the STI + Resistance Panel Assay for Research Use Only
Applied BioCode now offers STI + Resistance Panel on the BioCode® MDx-3000 system for research use only (RUO).
April 15, 2024
·
4 min read
Biotech Beach
Applied BioCode Announces the Launch of the Fungal Panel Assay for Research Use
Applied BioCode now offers Fungal Panel on the BioCode® MDx-3000 system for research use only.
June 12, 2023
·
4 min read
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
Applied Therapeutics Reports Fourth Quarter and Year-end 2024 Financial Results
April 14, 2025
·
10 min read
Business
Applied BioCode Appoints Industry Veteran Chris Bernard as Chief Executive Officer
Applied BioCode announced today that Chris Bernard has been appointed as their new Chief Executive Officer (CEO).
March 24, 2022
·
4 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
·
2 min read
·
Annalee Armstrong
FDA
Applied BioCode Obtains Emergency Use Authorization for CoV-2 Flu Plus Assay
Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US FDA for its BioCode® CoV-2 Flu Plus Assay.
December 16, 2021
·
3 min read
1 of 7,132
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