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624,757 Results for "food and drug law institute".
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Government
Trump’s Tax Law Restores Orphan Drug Exemptions, Cuts Medicaid, Threatens 340B Program and Gives PBMs a Pass
President Donald Trump’s One Big Beautiful Bill, signed into law last week, reintroduces broader exemptions for orphan drugs from the IRA’s drug price negotiation program—a move welcomed by the biopharma industry. The new tax law also cuts Medicaid funding, posing a minimal risk to pharma’s bottomlines and potentially jeopardizing hospitals’ 340B status. It does not, however, include new rules for pharmacy benefit managers that had been in an earlier draft.
July 8, 2025
·
3 min read
·
Tristan Manalac
Press Releases
Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration
October 2, 2025
·
4 min read
Press Releases
U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease
October 14, 2025
·
18 min read
Press Releases
Ascelia Pharma Submits Orviglance New Drug Application to the U.S. Food and Drug Administration
September 3, 2025
·
2 min read
Press Releases
Biocon Biologics Receives U.S. Food and Drug Administration Approval for Bosaya™ and Aukelso™, Denosumab Biosimilars
September 18, 2025
·
13 min read
Press Releases
Grace Therapeutics Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104
August 28, 2025
·
9 min read
Press Releases
Vivace Therapeutics’ VT3989 Granted Fast Track Designation by the U.S. Food and Drug Administration for the Treatment of Mesothelioma
October 8, 2025
·
2 min read
Press Releases
Medicus Pharma Ltd. Receives Positive Feedback From the Food and Drug Adminstration (FDA) Type C Meeting Supporting the Development of Skinject
September 30, 2025
·
10 min read
IN PARTNERSHIP WITH DIA
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
Cellectar Biosciences Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Iopofosine I 131 in Relapsed or Refractory Pediatric High-Grade Glioma
October 28, 2025
·
8 min read
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