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FDA
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.
IPO
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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Brand pharmas not only leverage ancillary patents but sometimes hide or misrepresent information to the U.S. patent office in order to extend market exclusivity and high prices.
The IPO window is starting to crack open this year, with Metagenomi and ArriVent making their offerings ahead of the J.P. Morgan Healthcare Conference.
The multimillion-dollar collaboration will develop small molecule drugs against undisclosed targets.
The patient deaths were deemed unrelated to Vertex’s investigational islet cell therapy, but the study will be halted while regulatory authorities and an independent data monitoring committee review the findings.
The state must submit additional information about the drugs it intends to import before the first shipments are sent to the U.S.
The therapeutic targets of many of our top startups are also reflected in recent big biopharma acquisitions and partnerships.
In a major pivot, Allogene Therapeutics will no longer focus on two of its studies testing blood cancer therapy cema-cel in an effort to extend its financial runway into 2026.
While initial public offering activity was light in 2023, the new year has recorded the first IPO plan—from California-based CG Oncology.
Eli Lilly on Thursday announced the rollout of a new digital healthcare platform to streamline consumer access to its weight-loss drug Zepbound and other medications.
With recent scientific advances, milestone approvals and increased dealmaking, the future of treatment for neurological diseases looks brighter—but continued investment, collaboration and patient-focused efforts are key.