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616,825 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
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3 min read
·
Tristan Manalac
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
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
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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
Press Releases
U.S. Food and Drug Administration Accepts for Review Allergan Aesthetics Premarket Approval Application for SKINVIVE by JUVÉDERM® for the Improvement of Neck Appearance
June 30, 2025
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16 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
US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA™ (adalimumab-bwwd) Injection
May 27, 2025
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19 min read
Press Releases
Aldeyra Therapeutics Receives Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration for ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma
June 26, 2025
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8 min read
Press Releases
U.S. Food and Drug Administration Approves CSL’s ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start
June 17, 2025
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9 min read
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