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The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
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.
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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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VBI Vaccines and Hepion Pharmaceuticals have received Orphan Drug Designations from the U.S. Food and Drug Administration for their experimental cancer drugs.
BMS, TG Therapeutics, Spero and Merck are all preparing for PDUFA dates over the next couple of weeks. Here’s a closer look.
Friday morning, the FDA granted Emergency Use Authorization to both Moderna’s and Pfizer-BioNTech’s COVID-19 vaccines for use in children ages 6 months to 4 years old.
The World Trade Organization approved vaccine patent waivers to increase the availability of COVID-19 vaccines to lower-income countries.
AstraZeneca appears to have taken an interest in Mereo BioPharma and may be considering a buyout, according to speculations published by The Times UK.
Addex Therapeutics announced it is canceling its Phase IIb/III study evaluating its drug dipraglurant due to patient recruiting, staffing and pandemic-related issues.
The vote came just over one week after the FTC announced it would probe claims regarding the role the middlemen play in determining retail prices of prescription drugs.
Genmab and AbbVie announce positive data in large b-cell lymphoma, Intra-Cellular’s bipolar depression candidate hits the endpoint in Phase III and more.
Researchers surveyed 60,000 Microsoft employees and found that remote workers are more productive than their in-office counterparts in the short-term, but less productive long term.
Atreca announced that Stephen Gould, Ph.D., will be the company’s next chief scientific officer. Most recently, Gould was executive director, of Translational Oncology at Genentech.