Latest News
& Press Releases

Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.

TOP STORIES
Encouraging data for combination regimens of Revolution Medicines’ zoldonrasib “reinforce the path to leadership in PDAC” for the biotech, according to Truist Securities.
The approval of Ionis Pharmaceuticals’ Tryngolza for severe hypertriglyceridemia could spur “substantial growth” for the product, according to William Blair.
Gilead’s Trodelvy can now be used as a monotherapy and in combination with Merck’s Keytruda to treat certain patients with triple-negative breast cancer.
FDA
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
Looking for a new role in and around San Francisco? Check out these companies hiring across all disciplines.
Recent BioSpace industry conference conversations point to sponsors pushing earlier on safety, quality and performance data, leading to demand for nitrosamine analysis, IVRT/IVPT and microbiome database capabilities.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Jubilant HollisterStier received a warning letter over problems that the FDA said necessitate an immediate and comprehensive assessment of the contract manufacturing organization’s global operations.
After 27 deaths were reported in a group receiving its blood cancer drug, ADC Therapeutics is downsizing, implementing layoffs for about 30 workers.
A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
FDA
A new report from RBC Capital Markets lists Biotechnology Innovation Organization chief executive John Crowley and military physician Heidi Overton as potential candidates for the role of FDA commissioner—in addition to the agency’s current acting leader, top food regulator Kyle Diamantas.
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
UPCOMING EVENTS
PRESS RELEASES
At this year’s annual meeting of the Bio International Convention (BIO) in San Diego, CA, TechBio company Cytomos (www.cytomos.com) is showcasing their flagship cell analytic intelligence platform AuraCyt® – together with its novel benchtop technology Celledonia® – which is set to revolutionise predictive cell analytics.
Human data demonstrates translation of key findings from preclinical studies
MARKET RESEARCH REPORTS