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In a letter to President Donald Trump, a group of biotech executives recommended former cancer regulator Richard Pazdur to lead the agency after the departure of Marty Makary.
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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 has accepted Sarepta’s BLA for the accelerated approval of SRP-9001, an investigational gene therapy for DMD. Roche is responsible for commercialization outside the U.S.
C4X entered into a licensing deal with AstraZeneca to develop an oral treatment for COPD and other inflammatory and respiratory illnesses that could reach $402 million.
A Phase III trial of Axsome Therapeutics’ AXS-05 hit both the primary and secondary endpoints in patients with Alzheimer’s disease agitation, the New York-based company announced Monday.
Many biopharma companies raised funds in 2022, but not enough to reach their next milestone. Investors have been constricting investments, so companies needing additional funding require a larger toolbox.
BioSpace spoke with Dr. Kiana Aran to discuss her life, her accomplishments and what it means to be a successful woman in science on a global scale.
BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.
Novartis and Medicines for Malaria Venture are moving into Phase III for a combination treatment targeting the rise of artemisinin-resistant Malaria infection.
Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”).
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.
The FDA approved CSL Behring and uniQure’s Hemgenix, a one-time gene therapy developed for adults with Hemophilia B,the companies announced Tuesday afternoon.