FDA approves Qelbree label update for ADHD treatment
ROCKVILLE, Md. - Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a biopharmaceutical company specializing in CNS diseases with an impressive 89% gross profit margin, has announced the FDA approval of a ...
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FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...
FDA proposes mandatory front-of-package nutrition labels to combat spike in chronic diseases
The U.S. Food and Drug Administration (FDA) is demanding increased, in-your-face food transparency when it comes to nutrition ...
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Novo Nordisk secures FDA approval for Ozempic in diabetes with CKD
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks ...
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FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
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FDA Approves New Maintenance Dosing for Lecanemab to Treat Early-Stage Alzheimer Disease
The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...
JD Supra7d
FDA Finalizes Guidance for Communications About Unapproved Uses to HCPs, Clarifying Multiple Standards
The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding ...
FDA approves standalone use of J&J's ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's nasal spray, Spravato, to allow it to be used ...
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MSD wins FDA priority review for Welireg in rare endocrine cancer
The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...