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621,171 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
Ascelia Pharma Submits Orviglance New Drug Application to the U.S. Food and Drug Administration
September 3, 2025
·
2 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
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
MAXONA PHARMACEUTICALS SUBMITS INVESTIGATIONAL NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION FOR MAX-001
August 8, 2025
·
4 min read
Press Releases
Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD
August 29, 2025
·
7 min read
Press Releases
Evolus Announces Submission of Premarket Approval Application to the U.S. Food and Drug Administration for Evolysse™ Sculpt Injectable Hyaluronic Acid Gel Product
August 21, 2025
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5 min read
Press Releases
Medicus Pharma Ltd. Announces Submission of Product Development Plan to the Food and Drug Administration (FDA) to Treat External Squamous Cell Carcinoma (SCC) in Horses
Company Is Advancing Use of Novel Doxorubicin-containing Microneedle Array (D-MNA) Patch in Veterinary Oncology as an Orphan Drug
June 9, 2025
·
10 min read
Press Releases
Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104
June 25, 2025
·
9 min read
Press Releases
Medicus Pharma Ltd. Announces Submission of Type C Meeting Request to the Food and Drug Administration (FDA)
July 8, 2025
·
8 min read
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