Valneva said regaining full rights to the vaccine will allow the company to “assume direct control over its supply chain and commercialization for endemic high-risk countries
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 FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
Dr. Chand held several leadership positions within AstraZeneca and the broader biopharmaceutical industry
Coverage has been significantly strengthened across key therapeutic categories, including anti-tubercular, anti-diabetic and anti-cancer medicines, as well as iron supplements, thereby ensuring more comprehensive standardisation of medicines used under various National Health Programmes
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
The approval is supported by data from three pivotal clinical trials
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