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As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
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FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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In its fourth-quarter earnings report, Moderna’s revenue was down substantially from 2023. Separately, media reports reveal anticipated cuts to the company’s digital team.
The failure in adjuvant melanoma could cause BMS and Opdualag to miss out on a market opportunity that is nearly twice as large as its current approved indication, according to analysts.
Amgen will continue to advance half of the combo, PRMT5 inhibitor AMG 193, for which it is running a mid-stage trial in MTAP-null advanced non-small cell lung cancer.
The experts will assess unblinded data from BEACON-IPF to figure out why a data safety monitoring board recommended suspension of the idiopathic pulmonary fibrosis trial.
Robert F. Kennedy Jr.—whose history of anti-vaccine rhetoric has had the healthcare and biopharma industries on edge—was confirmed as Health and Human Services Secretary in a Senate vote along party lines.
Encoded’s layoffs will mostly affect its technology and early-stage research and development functions. The move is expected to keep the biotech operational well into 2026.
Obesity drug developers Aardvark, Helicore and Metsera have all netted raises in the past two weeks.
Without providing specific data, Sanofi on Thursday announced that the experimental vaccine did not significantly prevent invasive E. coli disease versus placebo.
In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis and Tom Whitehead continue to discuss the patient and caregiver experience, where Tom gives his insights to the future of CGTs.
The data, published in JAMA Psychiatry, add to the growing body of evidence supporting the use of GLP-1 receptor agonists for addictive disorders.