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586,308 Results for "food and drug administration fda".
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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
Press Releases
Equillium Announces Feedback from the U.S. Food and Drug Administration
April 24, 2025
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5 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
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6 min read
Press Releases
U.S. Food and Drug Administration Updates CAMZYOS® (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications
April 17, 2025
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17 min read
FDA
FDA After the Storm: Drug Review Delays and Increased Executive Oversight Expected
After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.
April 14, 2025
·
6 min read
·
Heather McKenzie
Press Releases
Bonus Biogroup Announces U.S. Food and Drug Administration (FDA) Clearance of an Investigational New Drug (IND) Application for MesenCure™ Phase III Clinical Study in Respiratory Distress
February 21, 2025
·
9 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
Regulatory
Vanda Escalates Vendetta Against FDA, Blasts ‘Bureaucrats’ for Delaying Stomach Drug
The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.
April 24, 2025
·
2 min read
·
Tristan Manalac
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
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
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