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The FDA has previously linked eight deaths in the U.S. to Tavneos and has alleged that doctored data were used to support the drug application that led to its approval in 2021.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Takeda entered into an exclusive licensing agreement with Hutchmed Limited to develop its colorectal cancer candidate, fruquintinib, beyond mainland China, Hong Kong and Macau.
Sanofi licensed CytoReason’s inflammatory bowel disease model in a multi-million dollar bid to identify new therapies for IBD and Crohn’s and colitis.
The FDA granted Seagen’s tyrosine kinase inhibitor Tukysa accelerated approval for an aggressive form of colorectal cancer Thursday.
Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.
The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.
Disc Medicine inked an exclusive license agreement with Mabwell Therapeutics for the latter’s portfolio of monoclonal antibodies against the TMPRSS6 protein.
bluebird bio, Inc. is expecting gross proceeds of $120 million with its newly announced public offering of 20,000,000 shares.
Jazz Pharmaceuticals and Zymeworks announced results from a Phase II trial of the latter’s HER2-targeted antibody for metastatic gastroesophageal adenocarcinoma.
Roche’s Tecentriq (atezolizumab) combined with Avastin (bevacizumab) met the primary efficacy endpoint in early-stage hepatocellular carcinoma in the Phase III IMbrave050 study.
Editas announced the sale of its iPSC-derived iNK programs to Shoreline Biosciences. Shoreline also licensed Editas’ SLEEK technology.