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Last updated 2 days ago
FDA rejects Disc’s rare disease drug despite commissioner’s voucher
2 days ago
The FDA has rejected a rare blood disease candidate from Disc Medicine...
‘It’s really a dire time for patients’: Biohaven CEO says FDA red tape is blocking access to rare disease treatments
2 days ago
After a string of high-profile regulatory rebukes, Biohaven’s CEO believes red tape...
With the FDA's Moderna decision, vaccine makers face increasingly uncertain regulatory environment
2 days ago
The regulatory environment in the United States encountered by Moderna during the...
After R&D head exits, Immunocore CEO pairs ambition with caution for growing cancer portfolio
2 days ago
With sales of Immunocore’s melanoma medicine steadily ticking up, an expanded label...
FDA clears Encora Therapeutics’ wearable wrist device for essential tremor
2 days ago
For millions of Americans with essential tremor, simple tasks like writing a...
What were the biggest clinical trial flops of 2025?
2 days ago
On this episode of "The Top Line," Fierce Biotech's James Waldron and...
Moderna R&D spend shrunk 31% in 2025 amid major pipeline reorg
2 days ago
mRNA specialist Moderna's R&D spend sunk by nearly a third last year...
Integra LifeSciences cuts roles as 65 staffers impacted from Princeton, N.J., site
2 days ago
One month after Integra LifeSciences recalled its wound and burn devices amid...
Chutes & Ladders—Sanofi's stunning CEO switch
2 days ago
Sanofi is replacing CEO Paul Hudson with Merck KGaA leader Belén Garijo...
Ultragenyx lays off 10% of workforce as FDA continues to stall gene therapy approval plans
2 days ago
Ultragenyx's employees were already braced for changes as the biopharma considered how...
‘When the markets opened, we were ready’: Why biotech IPOs are back for 2026
2 days ago
Whisper it, but we may finally be seeing the IPO window reopening...
Lundbeck’s migraine prevention treatment sees ph. 2 success after trial’s earlier setback
3 days ago
After scrapping one portion of the trial, Lundbeck’s intravenous monoclonal antibody has...