GH Research is scheduled to update on the FDA status of GH001 and outline its global Phase 3 plans for treatment-resistant ...
A new rule from the Food and Drug Administration (FDA) will update what it means for food to be labeled “healthy” for the first time in 30 years, a move that aligns with current nutrition science and ...
The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials ...
This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs. In September 2024, the much-anticipated update to FDA’s Guidance ...
Following the FDA’s routine inspection at Fagron’s Wichita facility conducted in June 2024, the Company received a warning letter from the FDA (Warning Letter) on December 19, 2024. The Warning Letter ...
Leqvio's label update allows its use as a first-line monotherapy for LDL-C reduction in hypercholesterolemia, reflecting strong PCSK9-targeting evidence. The update addresses an unmet need, as many ...
Just before the end of 2025, an oral version of a GLP-1 drug specifically used for weight management moved much closer to reality. On December 22, the U.S. Food and Drug Administration (FDA) approved ...
Amid the end of a national GLP-1 shortage, the FDA will now require all compounding, distributing, or dispensing of compounded tirzepatide injections to end within 90 days. The FDA has updated its ...
The FDA’s emerging framework represents more than a regulatory update; it is a paradigm shift toward human-relevant, science-forward drug development. By reducing reliance on animal models and ...
US patients with idiopathic pulmonary fibrosis will no doubt welcome news that regulators have approved the first two medicines for the progressive and fatal lung disease. US patients with idiopathic ...
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF THE MARKET ABUSE REGULATION (EU) 596 / 2014 WHICH FORMS PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 . De Novo ...
A popular brand of artisanal water based out of Hawaii has recalled tens of thousands of bottles after customers complained about ‘floating particles.' Waiakea Bottling Inc., known for its ...