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
Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Funding announcements can signal future hiring activity, giving biotech professionals a chance to build relationships before positions are posted. Industry experts share how to identify the funding events, milestones and company indicators most likely to lead to new jobs.
The biologics license application follows months of public speculation—and regulatory reversals—for uniQure’s AMT-130. If accepted by the FDA for priority review, approval could come in the second quarter of 2027.
Efficacy plateaus, muscle loss and weight rebound are testing the limits of GLP-1 success, pushing companies toward new mechanisms and multitarget designs to close the gap. But progress depends on understanding disease biology and selecting the right drug candidates to derisk clinical trials.
CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the FDA.
Novartis is planning to file for remibrutinib’s expanded approval in relapsing multiple sclerosis by next year, putting it just behind Roche’s own BTK inhibitor fenebrutinib.
Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme.
Almost as many biotechs have opted for a reverse merger to reach the public markets as those executing more traditional initial public offerings this year.
BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers.