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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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Merck’s bid to buy the cancer-focused Seagen has hit a roadblock after the two companies failed to agree on a price, according to a Bloomberg report.
The United States and China are reportedly close to an agreement that would allow the PCAOB to audit companies listed on the U.S. stock exchange, per the Wall Street Journal.
In an SEC filing, Zymergen revealed it was cutting 80 more jobs and parting with Zach Serber, its co-founder and chief scientific officer.
Pfizer’s RSV vaccine has produced promising data with an efficacy of 85.7% in adults over 60 with a more severe form of the disease. Data in hand, Pfizer plans to head to the FDA this Fall.
This week’s Movers & Shakers includes Tessa and Adial bringing in new CEOs, while other companies strengthened their regulatory and medical teams with key appointments
Erytech Pharma is abandoning plans to submit a Biologics License Application to the FDA for Graspa in hypersensitive acute lymphoblastic leukemia.
AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, to treat non-small cell lung cancer, myasthenia gravis and breast cancer, respectively.
BioMarin’s Roctavian was granted conditional authorization in the European Union, making it the first gene therapy approved for severe hemophilia A. Now, the company is shooting for U.S. approval.
NIH researchers found that symptomatic herpes viruses were associated with neurological symptoms, but there was no evidence that herpes viruses are linked to Alzheimer’s disease.
Bay Area-based 3T Biosciences launched Thursday with a technology platform its leadership team believes can change the future of treatment for solid tumors and immune-mediated diseases.