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Antibody-drug conjugate
GSK’s Blenrep DREAMMs Turn Fitful as FDA Questions Comeback in Multiple Myeloma
In advance of this week’s adcomm, the FDA flags ocular toxicities associated with the antibody-drug conjugate, which received accelerated approval in August 2020 but was pulled from the market two years later after a confirmatory trial failed to improve progression-free survival.
July 16, 2025
·
2 min read
·
Tristan Manalac
Mergers & acquisitions
Merck, AstraZeneca Cancer Collaborator Gets Swallowed Up by Sino Biopharm
Shanghai-based LaNova Medicines—which has captured the attention of some of the biggest Western pharmas—will be folded into fellow Chinese company Sino Biopharmaceutical in a deal worth up to $951 million.
July 16, 2025
·
1 min read
·
Tristan Manalac
Layoff Tracker
Ventus “Recalibrates” to Support Mid-Stage Trials
Follow along as
BioSpace
tracks job cuts and restructuring initiatives throughout 2025.
July 16, 2025
·
159 min read
·
BioSpace Editorial Staff
COVID-19
Vinay Prasad Overruled Reviewers on Moderna’s COVID-19 Shot for Kids
In a July 9 memo, the director of the FDA’s Center for Biologics Evaluation and Research contended there was not enough evidence that the benefits of Moderna’s COVID-19 vaccine Spikevax outweighed its risks in healthy children.
July 16, 2025
·
2 min read
·
Tristan Manalac
Press Releases
Johnson & Johnson Announces Quarterly Dividend for Third Quarter 2025
July 16, 2025
·
1 min read
Press Releases
Johnson & Johnson Reports Q2 2025 Results; Raises 2025 Outlook
July 16, 2025
·
20 min read
Press Releases
Genmab Announces Net Sales of DARZALEX® (daratumumab) for Second Quarter of 2025
July 16, 2025
·
3 min read
Podcast
FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
July 16, 2025
·
1 min read
·
Heather McKenzie
Press Releases
Piccolo Medical, Inc. Receives FDA Clearance for 2nd Generation SmartPICC® technology
July 16, 2025
·
3 min read
Career Advice
When Feedback Feels Off: Using Critique That Doesn’t Feel Fair
It’s easy to get caught up in defending yourself against critique that feels unfair. Leadership coach Angela Justice recommends a different approach that can help you better align how you want to be seen with how you’re showing up.
July 16, 2025
·
3 min read
·
Angela Justice
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