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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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Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.
The company reported second-quarter revenue Wednesday that included $248.4 million of back royalties and associated interest related to the successful outcome of an arbitration case with J&J’s Janssen.
With partner Biogen mum on zuranolone’s prospects as an FDA August 5 review deadline approaches, Sage Therapeutics’ stock fell Wednesday to its lowest level in months.
On the heels of a European Union investigation, the UK’s health agency is reviewing safety data for GLP-1 receptor agonists after reports of self-harm and suicidal thoughts.
In a recent study of the U.S. states with the best and worst job markets, nine came out on top. Read on for details about the life sciences industry and jobs available in each state.
The Phase III trial, which will test the companies’ mRNA-based personalized cancer vaccine and Merck’s blockbuster Keytruda checkpoint inhibitor, is slated for completion by the fall of 2029.
While GlaxoSmithKline is anticipating a slower uptake of respiratory syncytial virus vaccine Arexvy, CEO Emma Walmsley said Wednesday the company is pinning much of its growth on the vaccine’s performance.
The Federal Trade Commission’s increased scrutiny of mergers has now hit IQVIA, whose proposed acquisition of Propel Media has been challenged by the watchdog agency.
Following several clinical failures for its candidates Roxadustat and pamrevlumab, FibroGen CEO Enrique Conterno is stepping down for “personal reasons,” the company announced Tuesday.
Embattled SQZ Biotechnologies announced Tuesday that the Swiss biotech will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program.