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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.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
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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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Seattle-based Sana Biotechnology is moving on from its current Fremont, California manufacturing facility, inking a lease deal to develop a manufacturing plant in Bothell, Washington.
AstraZeneca CEO Pascal Soriot has been knighted in the Queen’s Birthday Honours for his contribution to life sciences and leadership during the COVID-19 pandemic.
Transition Bio has a four-component platform called Condensomics which provides a technological method to understand the properties of condensates.
Atreca is reducing its staff count by over 25%, covering current employees and open roles, and revising its operating plan to reflect these cost-cutting measures.
Biopharma and life sciences organizations from across the globe provide updates on their pipelines and businesses.
A largely untested and unproven treatment for Alzheimer’s disease, called transcranial pulse stimulation (TPS), is becoming popular around the world, although experts are skeptical.
Eligo Bioscience has thought of a way to solve the dysbiosis between our bodies and our microbiomes – gene editing. BioSpace spoke with Eligo Co-founder and CEOXavier Duportet, Ph.D.
FDA
Shares of TG Therapeutics are falling fast in Wednesday trading after the U.S. Food and Drug Administration announced it was pulling approval of the cancer drug Ukoniq (umbralisib).
Several new biotech and biopharma companies are sharing their strengths to develop new treatments for high-need diseases diabetes, Alzheimer’s and cancer.
The FDA has issued special designations that could improve the lives of millions with recurrent glioblastoma or hemophilia diagnoses.