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611,010 Results for "food and drug law institute".
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Webinar: AI, Regulation and the Law: Shaping the Future of Drug Development
In this discussion, our guests explore how recent regulatory changes are shaping the future of AI in drug development in the US market. Watch now.
April 23, 2025
·
1 min read
·
BioSpace Insights
Press Releases
Equillium Announces Feedback from the U.S. Food and Drug Administration
April 24, 2025
·
5 min read
Press Releases
U.S. Food and Drug Administration Updates CAMZYOS® (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications
April 17, 2025
·
17 min read
Press Releases
Kelun-Biotech’s novel ADC drug SKB518 has been granted the clearance of IND from the United States Food and Drug Administration (FDA)
April 21, 2025
·
2 min read
Immunology and inflammation
First Head-to-Head Study Cements Roche’s Xolair as Food Allergy Leader
Roche’s asthma drug Xolair appears to be safer and more effective than oral immunotherapy at treating adults and children with one or more food allergies.
March 3, 2025
·
2 min read
·
Tristan Manalac
Press Releases
Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease
April 3, 2025
·
10 min read
Press Releases
SynOx Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT)
April 14, 2025
·
4 min read
Press Releases
Applied DNA Positions TR8 PGx Testing Service as Pre-Emptive Testing for Safety of Fluoropyrimidine-Based Cancer Therapeutics Following Publication of Food and Drug Administration Safety Announcement
April 2, 2025
·
5 min read
FDA
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma
April 11, 2025
·
19 min read
Press Releases
Savara Completes Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
March 26, 2025
·
6 min read
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