US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...
Yahoo Finance7d
J&J’s Spravato receives FDA label expansion for depression monotherapy
Initially approved in 2019 for use alongside oral antidepressants, this label expansion follows a priority review from the FDA. The approval was based on data from the Phase IV TRD4005 study ...
FOX 5 Atlanta13d
FDA proposes putting nutrition labels on the front of food packages
LOS ANGELES - The FDA unveiled a proposal Tuesday to require front-of-package nutrition labels on most packaged foods, a major step in combating chronic diseases. The labels, called "Nutrition ...
Medscape13d
FDA Pushes for Buprenorphine Labeling Changes to Facilitate Higher Doses
The US Food and Drug Administration (FDA) is urging manufacturers to revise labeling of transmucosal buprenorphine products to ease access to higher doses needed due to the rise of high-potency ...
Medscape1d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...
JD Supra3d
FDA Proposes Front-of-Package Labeling Requirements
On 14 January 2024, the US Food and Drug Administration (FDA) issued a proposed rule to be published on 16 January, which, if finalized, will require a front-of-package (FOP) nutrition label on ...
FiercePharma12d
AstraZeneca's Calquence and Amgen's Lumakras clinch FDA label expansions
Amgen’s Lumakras and AstraZeneca’s Calquence are both in line to expand their respective oncology reaches with new FDA ...
JD Supra13d
FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
The US Food and Drug Administration (FDA) has released its proposed rule on front-of-package (FOP) nutrition labeling. Announced on January 14, 2025, the proposed rule would add a requirement to ...
The National Law Review9d
FDA Proposes Front-of-Package Labeling Requirements
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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 ...
Zacks.com on MSN1d
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 ...