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629,127 Results for "food and drug law institute".
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Press Releases
Roxadustat Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes by the U.S. Food and Drug Administration
December 15, 2025
·
6 min read
Press Releases
NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine
December 3, 2025
·
6 min read
Press Releases
PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)
December 3, 2025
·
6 min read
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
U.S. Food and Drug Administration Approves LIB Therapeutics’ LEROCHOL™ (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol
December 15, 2025
·
6 min read
Press Releases
Ophirex Announces Business Update: Advances Toward Food and Drug Administration (FDA) Approval for Varespladib as Novel Oral Snakebite Treatment
December 12, 2025
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5 min read
Press Releases
U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb’s Application for Opdivo® (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma
December 12, 2025
·
19 min read
Press Releases
Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration
October 2, 2025
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4 min read
Press Releases
Genmab Announces EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide Approved by the U.S. Food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma
November 19, 2025
·
17 min read
Press Releases
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
November 21, 2025
·
9 min read
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