NVO gains CHMP backing for a higher-dose Wegovy, paving the way for potential EU approval in 2026 as study data show stronger ...
Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a ...
FDA-approved weight loss medications include injections (Wegovy®, Zepbound®, etc.) and pills, like Qsymia® and Xenical®. Most ...
EMA issues positive opinion on Novo Nordisk's higher-dose Wegovy, supported by strong weight-loss data and ongoing reviews in ...
The U.S. Food and Drug Administration said on Monday it ‍has granted a national priority voucher to Johnson & Johnson's blood ...
The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with metabolic ...
News and commentary from the endocrinology world ...
The European Medicines Agency (EMA) has issued a positive opinion for a new Wegovy® 7.2 mg dose, advancing its availability ...
Top FDA officials have internally pushed for a faster review of Eli Lilly’s (LLY) marketing application for its weight loss pill orforglipron. Read more here.
The first CNPV approval falls into the latter category, and is for a US-manufactured version of the widely used antibiotic ...
The inaugural approval under the program has gone to USAntibiotics and its domestically manufactured extended-release ...
Novo Nordisk's 7.2 mg Wegovy injectable aims to enhance chronic weight management in adults with obesity, using an expedited FDA review process. The Phase III STEP UP trial showed semaglutide 7.2 mg's ...