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The company won the third FDA approval in a month for the anti-PD-1 blockbuster, allowing its first-line use in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
To help cope with the high demand for weight-loss treatments, Eli Lilly is investing $2.5 billion in a German manufacturing facility after last week’s FDA approval of Zepbound for chronic weight management.
When given hours ahead of an expected episode, a late-stage study showed the preventive benefits of Ubrelvy in safely reducing moderate or severe headaches within 24 hours of treatment.
BioSpace takes a deep dive into five investigational therapeutic cancer vaccines that have recently shown efficacy in difficult-to-treat indications.
After Bristol Myers Squibb picked up Augtyro as part of its $4.1 billion takeover of Turning Point Therapeutics last year, the ROS1-positive non-small cell lung cancer drug reached the regulatory finish line on Wednesday.
The Japanese pharma contends that an analysis of the four deaths in its AT132 gene therapy clinical trial shows it is still viable as a potential treatment for a fatal, rare genetic disease.
The U.K.’s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.
Just a week after it secured FDA approval, Eli Lilly’s Zepbound now faces a challenge from Novo Nordisk’s investigational next-generation weight-loss candidate CagriSema in a Phase III trial.
Approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, CorMedix’s DefenCath reduces the incidence of catheter-related bloodstream infections in adult hemodialysis patients.
This is part one of a discussion focused upon data bias, accuracy, access and the future of AI in drug development. Topics explored are ROI, human bias, data challenges, data management plans, and human expertise.
Successful drugs from Novo Nordisk and Eli Lilly are just the beginning of what one analyst says could be “the largest therapeutic class of drugs that the biopharma industry has ever seen.”
After a Phase III trial did not meet its primary endpoint, Bayer will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market following discussions with the FDA.