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608,378 Results for "food and drug law institute".
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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
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
Press Releases
Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma
February 10, 2025
·
7 min read
Press Releases
Tempest Receives Orphan Drug Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma (HCC)
January 6, 2025
·
7 min read
Press Releases
PacBio Names Global Institute for Food Security as Canada’s First Revio Certified Service Provider
January 23, 2025
·
5 min read
Policy
BWXT Medical Submits Drug Master File for Actinium-225 API to U.S. Food and Drug Administration
BWXT Medical Ltd. has submitted a Drug Master File to the U.S. Drug and Food Administration for No Carrier Added Actinium-225 Active Pharmaceutical Ingredient.
June 7, 2024
·
3 min read
Press Releases
U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome
December 20, 2024
·
8 min read
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