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FDA approves add-on therapy to lower cholesterol among certain high-risk adults
… Action FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with … Drug Evaluation and Research … FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with …
January - March 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
… of immune-mediated colitis. Lemtrada labeling Leqvio (inclisiran) Hypersensitivity The “Contraindications” and …
Notable Approvals | Drugs
… among certain high-risk adults 12/22/2021 Leqvio inclisiran FDA approves drug to treat, help prevent types of …
Novel Drug Approvals for 2021
… atopic dermatitis Drug Trials Snapshot 49. Leqvio inclisiran 12/22/2021 To treat heterozygous familial …
List of Pregnancy Exposure Registries
… Phone: 1-800-745-4447 (No webpage) Ongoing LEQVIO (inclisiran) Primary hypercholesterolemia Monitoring of pregnancy outcomes in women treated with inclisiran: a non-interventional study Phone: 1-888-669-6682 …
Drug Trials Snapshots: LEQVIO
… for additional uses of the drug (if applicable). LEQVIO (inclisiran) (leck’ vee oh) Novartis Pharmaceuticals Corp …
Table of Pharmacogenomic Biomarkers in Drug Labeling
… Studies Imipramine Psychiatry CYP2D6 Precautions Inclisiran Endocrinology Nonspecific (Heterozygous Familial …
FY 2024 Awarded GDUFA Science and Research Contracts and Grants
2021 Advancing Health Through Innovation -- New Drug Therapy Approvals
CDER Drug and Biologic Approvals for Calendar Year 2021
Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development
Challenges and Progress in Emerging Complex Generic Oligonucleotide Products
CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year 2021
FY 2024 Q1 Real Time Report - Generic Drugs
OND_DTS_SummaryReport_FINAL_220422
Written Requests Issued
fy_2024_q2_report_shell_-_generic_drugs_508.pdf