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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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FibroGen is tangled up in a Securities Class Action Litigation and Derivative Litigation concerning clinical trial data for its drug Roxadustat.
First Moscow State Medical University has paused recruiting new patients for its ongoing clinical trials following a disruption in the university’s ability to receive clinical trial samples.
The FDA asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details on how SARS-CoV-2 donor samples will be shipped to the vendor.
Shares of Adagene Inc. are up more than 10% in premarket trading after the company announced a monoclonal and bispecific antibody collaboration with Sanofi valued at up to $2.5 billion.
Flagship will pour in $75 million into Vesalius to support its beginnings, while Rondo raised $67 million to support the development of its preclinical pipeline.
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Belgium-based Celyad Oncology voluntarily paused a clinical trial with Merck after two deaths. Getting CAR T therapies to work in solid tumors has proven to be a difficult challenge.
Throughout history, many different countries have had their biopharma supply chains changed – sometimes profitably, sometimes detrimentally – by war.
The study, which has yet to be peer-reviewed, found the Pfizer-BioNTech vaccine was only about 12% effective for children ages 5 to 11 years against the Omicron variant.
WIES fellows will have access to successful female entrepreneurs, including CRISPR pioneer and Nobel laureate Jennifer Doudna, who founded the IGI.
AbbVie has bolstered its neuropsychiatric and neurodegenerative portfolio with the acquisition of Belgium-based Syndesi Therapeutics in a deal valued at up to $1 billion.