FDA delays Corcept’s hypertension drug, seeks more evidence
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
Syrma Johari is a globally recognised medical device engineering and manufacturing organisation
The Phase II study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of 9MW3811 in patients with pathological scarring
Elanco expects Befrena to launch in the US in the first half of 2026
Biotium reports that GlycoLiner Labelling is fully covalent and compatible with standard fixation and permeabilization protocols
Cupid is strengthening its footprint in the GCC region, focusing on supply responsiveness and market proximity
The decision secures legal protection in China for semaglutide, the blockbuster drug underpinning Novo Nordisk’s diabetes and obesity treatments
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