News
While Daiichi Sankyo brought in $13.4 billion in 2025, setbacks forced the company to update its antibody-drug conjugate forecast, pushing demand below the minimum supply agreed upon with CMOs and prompting the cancellation of an in-house investment.
FEATURED STORIES
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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 LATEST
While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi.
Data from Phase III confirmatory MIRASOL trial show antibody-drug conjugate boosts survival in platinum-resistant ovarian cancer, setting the stage for full approval by the FDA.
The regulatory decision marks a turning point in the RSV race in what’s expected to be a competitive space.
Despite the Phase III failure, Travere and partner CSL Vifor will explore potential regulatory paths for sparsentan as a treatment for focal segmental glomerulosclerosis.
Many employers aren’t offering the high salaries employees had grown accustomed to in recent years, leaving workers to decide whether they should accept a pay cut.
The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter.
The company’s pipeline changes come as it weathered a nearly 30% decline in first-quarter revenues due to a slowdown in its COVID-19 business.
Japanese biopharma scoops up Iveric’s investigational drug for age-related blindness disease. The drug, which trails Apellis’ Syfovre, is awaiting FDA approval with a decision expected by August.
The Oncologic Drugs Advisory Committee voted 11–1 supporting Merck’s and AstraZeneca’s PARP inhibitor for metastatic castration-resistant prostate cancer patients with BRCA mutations.
Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder.