News
Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 for Pompe disease.
FEATURED STORIES
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
THE LATEST
Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA proposal made during the negotiation process for the eighth cycle of the user fee program.
Last week, Center for Biologics Evaluation and Research Director Vinay Prasad claimed in an internal memo—without providing evidence—that COVID-19 vaccines were responsible for the deaths of 10 children between 2021 and 2024.
Høeg is the fifth person to lead the Center for Drug Evaluation and Research this year.
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for new approach methologies (NAMs) development.
With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points.
Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.
Analysts had noted “unease” from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a “significant development.”
The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.
For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating the need for six-month testing.
Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.