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Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.
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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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In the Phase III MELODY trial, researchers found a 74.5% lower incidence of respiratory syncytial virus-caused pneumonia, and bronchiolitis. Here’s more about it.
The FDA has not yet issued any hold orders to Cassava, but the company expects that its time is coming after rivals Denali and Cortexyme received theirs.
Recent gene therapy research has created a durable response in terms of producing normally-shaped red blood cells and reducing the pain of sickle cell disease.
Dr. Julie L. Gerberding, Merck’s chief patient officer and executive vice president of population health and sustainability, is retiring from Merck after 12 years.
The Phase III study showed that ELGN-GI not only improved gastrointestinal (GI) function, but it also reduced life-threatening complications.
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
LEXEO Therapeutics has announced positive initial data from its Phase I/II trial of LX1001, a gene therapy intended for the treatment of APOE4 homozygous Alzheimer’s disease (AD).
President Biden announced updates to the “Test to Treat” initiative that will allow people to get tested for COVID at a pharmacy and receive a treatment round of Pfizer’s Paxlovid at no cost.
Pfizer announced its RSV vaccine candidate PF-06482077 or RSVpreF, received Breakthrough Therapy designation from the U.S. Food and Drug Administration.
After Karyopharm submitted Phase III data from its SIENDO study on Selinexor, the FDA said that it is unlikely to support an sNDA approval for the drug.