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Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
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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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The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
Rhythm Pharmaceuticals published data Monday showing Imcivree (setmelanotide) improved quality of life for patients with obesity related to Bardet-Biedl Syndrome.
J&J’s Janssen terminated its integrin research collaboration with Morphic Therapeutics. This follows the June 2022 termination of a partnership with AbbVie.
Phase III data showed Ipsen’s Onivyde boosted overall survival in metastatic pancreatic ductal adenocarcinoma.
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.