Browsing: Clears

The U.S. Food and Drug Administration (FDA) has cleared for marketing an innovative blood test with underlying technology invented at Washington University School of Medicine in St. Louis for the early diagnosis of Alzheimer’s disease. The test, known as PrecivityAD2, was developed and validated by C2N Diagnostics, a WashU startup company

The Medicines and Healthcare products Regulatory Agency confirmed on 10 August that it had authorised orforglipron, sold under the brand name Foundayo, making Britain the first country in Europe to licence an oral GLP-1 receptor agonist for both weight management and type 2 diabetes. Julian Beach, the MHRA’s executive director of healthcare quality and access,…

Boulder, Colorado-based Enveda has reported Phase I results for ENV-308, an oral small molecule designed to mimic Lac-Phe, a hormone the body produces during high-intensity exercise, positioning the drug as a potential maintenance therapy for patients who discontinue GLP-1 receptor agonists and subsequently regain weight

A Phase 1 trial has supported the gastrointestinal safety profile of Enveda’s “exercise in a tablet” asset, encouraging the biotech to assess if the drug candidate can maintain the benefits of GLP-1 medicines

Eli Lilly (NYSE:LLY) just added another weapon to its obesity arsenal. The pharmaceutical giant received British authorization for Foundayo on Monday, making the U.K. the first European country to clear the once-daily orforglipron tablet for weight management and type 2 diabetes. Lilly shares rose approximately 2.1% in regular trading. The appeal is easy to understand:…

Legal challenge to King’s College London research study claimed it could harm participants but was rejected

India’s seam stocks were down to Siraj, Prasidh Krishna and an uncapped Punjab quick. The clearance changes the shape of the Galle Test

Brazil’s national drug regulator approved five semaglutide injection pens simultaneously on Wednesday — the largest single-day batch of GLP-1 receptor agonist clearances any health agency has issued in the country’s history — yet none of the drugs can reach a pharmacy shelf until Brazil’s drug pricing chamber sets a price cap, a separate regulatory step…

Eli Lilly (LLY, Financials), a pharmaceutical firm that focuses on diabetes, obesity and other chronic diseases, said it aims to petition for regulatory approval of retatrutide in the first quarter of 2027 after the medicine succeeded in two more phase 3 trials

Partners Hengrui Pharma and Kailera Therapeutics revealed Tuesday that two China-based late-stage trials evaluating an investigational small molecule GLP-1 receptor have hit their main goals, prompting Hengrui to tee up plans for regulatory submission in the Asian country