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The newly proposed salary increase for NIH-funded postdocs would not make the positions competitive with what the industry offers, experts said.
While the FDA considers a T cell malignancy risk to be applicable to all commercial CAR-T therapies, Gilead Sciences’ Tecartus has a revised warning that potential adverse events “may” occur.
The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
While decentralized trials are expediting innovation and promoting diversity, challenges remain, including complex stakeholder ecosystems, skills gaps and regulation.
The company said it’s preparing to file a New Drug Application with the FDA on the strength of late-stage study data for its investigational RNA-targeted donidalorsen in patients with hereditary angioedema.
An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.
In a Phase I/II trial, an 11-year-old boy gradually regained hearing—eventually reaching normal range for some frequencies at 30 days—following treatment with Eli Lilly’s dual adeno-associated viral vector-delivered gene therapy.
Drug discovery requires complex and multi-faceted decisions to justify billion-dollar investments that will take years to realize.
This week, Lori, Greg and Tyler discuss the first surge of IPO activity this year plus gene therapy pricing,
The Danish pharma has signed a collaboration and license agreement with Swiss biotech EraCal Therapeutics to access a novel candidate for controlling appetite and body weight.
The two biopharmaceutical industry organizations entered Medicare price negotiations after the loss of several prominent members and executives.
After showing some unfavorable results for its data, AC Immune on Monday announced it will be getting back its Alzheimer’s disease candidates from Roche’s Genentech.
PRESS RELEASES
Phio’s Presentation to take place on Wednesday January 28, 2026 at 9 AM ET
Australia’s Department of Health has issued import permits for Optimi’s MDMA and psilocybin capsules for use under the Authorised Prescriber Scheme
Execution layers are required to turn AI recommendations into governed action in regulated workflows.