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Zacks Investment Research on MSN3d
Bayer Gets FDA Nod for Label Expansion of Kerendia in Heart Failure
Bayer AG BAYRY announced that the FDA has approved a label expansion of kidney disease drug Kerendia (finerenone). The ...
MedPage Today on MSN8d
FDA Approves Label Change for Alzheimer's Amyloid Drug
The FDA approved a label update with a new titration schedule for donanemab (Kisunla), an anti-amyloid drug approved to treat ...
The Hill2y
We tried to improve COVID vaccine labeling — the FDA said ‘no thanks’
Health care providers rely on product labeling for accurate, unbiased and up-to-date information on medical products. But current Food and Drug Administration (FDA)-approved labels for the ...
JD Supra1y
FDA Proposes to Overhaul Labeling Requirements for Approved or ...
The FDA intends the proposed rule “to provide consistent formatting of new animal drug labeling” and cites several issues as the impetus of these proposed rules—chief among them that the ...
Yahoo Finance1mon
FDA approves label expansion of AbbVie hepatitis C therapy
In May 2025, AbbVie signed a partnership and licensing agreement with US-based ADARx Pharmaceuticals, committing $335m upfront to access its small interfering RNA platform. "FDA approves label ...
STAT6y
Many doctors uncertain about FDA approvals — and dislike off-label ...
Many doctors are uncertain about the FDA approval process — and don’t like off-label marketing. By Ed Silverman Jan. 30, 2019. Reprints. APStock.
JD Supra3y
FDA Issues Final Rule Clarifying Evidence of Off-Label Marketing
In the Final Rule, the FDA added the following language to the “intended use” regulations to clarify that a manufacturer’s, distributor’s, or other seller’s knowledge that a product is ...
CNET6y
FDA approved vs. FDA cleared: Why you need to know the difference
"FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use." ... don't be turned off by that label.