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Policy
FDA Policy Tracker 2026: One-Trial Drug Applications, Guidelines for Personalized Therapies
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
February 27, 2026
·
7 min read
·
Heather McKenzie
Regulatory
Makary Defends FDA’s Decision-Making Amid Contentious Rare Disease Rejections
Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically into the brain, that the FDA was “pressured” to approve even after finding no clinical benefit to patients.
February 27, 2026
·
2 min read
·
Tristan Manalac
IPO tracker
Generate’s IPO Could Reach $425M, Largest Raise Yet
Analysts are cautiously optimistic about an IPO rebound for biopharma.
BioSpace
is keeping track of companies that seek to trade on the public markets this year.
February 27, 2026
·
5 min read
·
Tristan Manalac
Press Releases
WuXi XDC Enters Strategic Collaboration with Earendil Labs on WuXiTecan-2 Payload-Linker Technology Platform
February 27, 2026
·
4 min read
Press Releases
Galderma’s Nemluvio® (nemolizumab) Demonstrates Long-Term Disease Control in Prurigo Nodularis up to Three Years
February 27, 2026
·
8 min read
Press Releases
Hemogenyx Pharmaceuticals PLC Announces Total Voting Rights
February 27, 2026
·
1 min read
Press Releases
Earendil Labs Enters Strategic Collaboration with WuXi XDC on WuXiTecan-2 Payload-Linker Technology Platform
February 27, 2026
·
4 min read
Press Releases
Year-End Report 2025
February 27, 2026
·
8 min read
Press Releases
Santhera Announces Proposed Inclusion and Reimbursement of AGAMREE® (Vamorolone) within Spain’s National Health System for the Treatment of Duchenne Muscular Dystrophy
February 27, 2026
·
4 min read
Special edition
Deep Dive: BioSpace Takes On JPM26 in San Francisco
The
BioSpace
team hit the ground running at the J.P. Morgan Healthcare Conference earlier this month to bring you the news from the streets of San Francisco.
February 27, 2026
·
2 min read
·
Annalee Armstrong
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