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Press Releases
Aadi Bioscience to Report Fourth Quarter and Full-Year 2024 Results and Corporate Update
March 17, 2025
·
1 min read
Press Releases
Junshi Biosciences Announces 2024 Full Year Financial Results and Provides Corporate Updates
March 31, 2025
·
11 min read
Press Releases
Cellectar Biosciences Reports Financial Results for Year Ended 2024 and Provides a Corporate Update
March 13, 2025
·
11 min read
Press Releases
Brii Biosciences Provides Corporate Update and Reports Full-Year 2024 Financial Results
March 24, 2025
·
11 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
Press Releases
Sagimet Biosciences Reports Full Year 2024 Financial Results and Provides Corporate Updates
March 12, 2025
·
12 min read
Press Releases
Spruce Biosciences Announces New Corporate Strategy and Acquisition of Tralesinidase Alfa for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
April 15, 2025
·
7 min read
Press Releases
Enveric Biosciences Reports Financial Results and Provides Corporate Update for Fourth Quarter and Fiscal Year Ended 2024
April 1, 2025
·
8 min read
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