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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
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The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. “The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the meeting, but many other factors will ensure this new drug class can benefit patients.
Analysts believe Cullinan Therapeutics and Taiho Oncology can overcome the safety risks as zipalertinib “sets [a] new bar” for first-line treatment of a type of lung cancer. The candidate is already under review for the the second-line setting, with a decision expected by early next year.
After inking a T cell engager pact with Chimagen Biosciences a few years ago, GSK is back for more, this time acquiring a multiple myeloma program from the antibody specialist.
GSK is consolidating its vaccine manufacturing operations to one site—located in Canada—amid the pharma’s recent $2.5 billion savings campaign.
Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.
After years of price pressures, the trade group argues “the economics of generics have deteriorated to the point where sustainability of the industry is in peril.”
This guide explores the evolving role of podcasts, webinars, and thought leadership programs in biopharma and provides practical recommendations for public relations agencies, corporate communications teams, and commercial marketers looking to elevate their visibility and influence.
PRESS RELEASES
Successful completion of GLP toxicology analysis for the intravenous administration of Rutherrin(R) lays the groundwork for regulatory submissions supporting first-in-human clinical development for multiple life-threatening cancers
Single-dose VINIA Daily Chews broaden demographics and usage occasions while demonstrating the commercial versatility of Botanical Synthesis Format expansion shows how BioHarvest can help CDMO partners move from plant-cell compositions to differentiated consumer products
Proprietary TeloView® blood-based TELO-MRD assay detected residual myeloma cells in a higher proportion of matched samples than bone-marrow next-generation flow cytometry in a University of Athens comparison.