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609,775 Results for "food and drug law institute".
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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
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
IRA
Drug Pricing and the Uncertain Future of the IRA Under Trump
While the former Biden administration showcased the Inflation Reduction Act as a key victory in the fight over high drug prices in the U.S., Trump has so far been mum on how the controversial law could evolve in the coming years.
January 31, 2025
·
4 min read
·
Jef Akst
Press Releases
Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
March 3, 2025
·
7 min read
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
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