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Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The U.S. Centers for Disease Control and Prevention is under fire for failing to publish large swaths of hospitalization data related to the COVID-19 pandemic.
BioNTech and Medigene announced a global agreement to develop T-cell immunotherapies against cancer. The three-year collaboration will focus on multiple solid tumor targets.
Eli Lilly is investing $700 million to build a state-of-the-art facility in Boston, as part of plans to advance its RNA-based therapeutics research and development activities.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
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AstraZeneca and Daiichi Sankyo released positive data from their Phase III trial of Enhertu. An alternative to chemotherapy for some HER2 low breast cancer.
BioSpace covers the Intelligence Squared U.S. debate: Will gene editing enable a healthier, more diverse, more equitable population, or will it create market-born eugenics and a dystopian society?
It was noted early in the COVID-19 pandemic that the disease was peculiar — not only was it a respiratory disease, but it created hyper-immune responses.
Prescription drug costs have continued to rise, with more than 150 drug manufacturers raising their prices in January.
The FDA asked Homology Medicines to modify the pheNIX gene therapy trial’s risk mitigation measures to prevent any serious issues that may arise.