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FDA

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Editorial
All the Ways Moderna’s Flu Vaccine Rejection Letter Shocked Us
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
February 11, 2026
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4 min read
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Dan Samorodnitsky
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Vaccines
FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies
February 11, 2026
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4 min read
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Tristan Manalac
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Regulatory
Hims & Hers’ Woes Compound as FDA Hits Company With Warning Letter
February 10, 2026
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2 min read
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Tristan Manalac
Complete response letters
REGENXBIO’s Hunter Syndrome Gene Therapy Fails To Win FDA Nod
February 10, 2026
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2 min read
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Tristan Manalac
Opinion
2025 Reshaped the FDA. What Will 2026 Hold?
February 9, 2026
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6 min read
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Claire Davies
Policy
FDA Policy Tracker 2026: Priority Vouchers Questioned, PRVs Return
February 9, 2026
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5 min read
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Heather McKenzie
Job Trends
3 Top Challenges Facing Regulatory Professionals Right Now
February 5, 2026
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4 min read
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Angela Gabriel
FEATURED STORIES
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Rare diseases
Despite Wide Support for Rare Disease, Voucher Program Caught Up in Senate’s ICE Fight
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
January 30, 2026
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3 min read
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Annalee Armstrong
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Rare diseases
Rare Disease Biotechs Stand To Lose $4B if Priority Voucher Program Not Reinstated: Report
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
January 26, 2026
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7 min read
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Heather McKenzie
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Opinion
To Accelerate Rare Disease Progress, Take a Sandbox Approach
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
January 26, 2026
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5 min read
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Oxana Iliach
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Policy
Biopharma Update on the Novel Coronavirus: September 30
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 30, 2020.
September 22, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 28, 2020.
September 22, 2020
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2 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 25
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 25, 2020.
September 22, 2020
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4 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 23, 2020.
September 22, 2020
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5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.
September 21, 2020
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2 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
September 17, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
September 16, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.
September 14, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.
September 10, 2020
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2 min read
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BioSpace Editorial Staff
Treatment of asthma coming very soon.
FDA
GSK’s Trelegy Ellipta Wins Approval as Treatment of Asthma
GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. Here’s what you need to learn.
September 10, 2020
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2 min read
 · 
Alex Keown
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