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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
 · 
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
 · 
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
 · 
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
 · 
Tristan Manalac
Opinion
2025 Reshaped the FDA. What Will 2026 Hold?
February 9, 2026
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6 min read
 · 
Claire Davies
Policy
FDA Policy Tracker 2026: Priority Vouchers Questioned, PRVs Return
February 9, 2026
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5 min read
 · 
Heather McKenzie
Job Trends
3 Top Challenges Facing Regulatory Professionals Right Now
February 5, 2026
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4 min read
 · 
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
 · 
Oxana Iliach
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THE LATEST
FDA
FDA Gives UroGen’s Jelmyto Expedited Approval for Urothelial Cancer
Jelmyto is the first and only non-surgical treatment for patients with this indication. Here’s everything you need to know about it.
April 16, 2020
 · 
2 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020.
April 16, 2020
 · 
8 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Use of Ortho’s High-Throughput, Automated COVID-19 Antibody Test
Antibody tests, also called serological tests, test if the individual has been exposed to SARS-CoV-2, the novel coronavirus that causes COVID-19.
April 15, 2020
 · 
2 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
April 15, 2020
 · 
7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 14, 2020.
April 14, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Rutgers’ Saliva Test for COVID-19
The U.S. Food and Drug Administration granted emergency use authorization to Rutgers’ RUCDR Infinite Biologics for its test that uses saliva.
April 13, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 13, 2020.
April 13, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Stanford serology test is finally here.
FDA
Stanford Serology Test: Stanford Joins List of Organizations Offering COVID-19 Antibody Testing
The Stanford serology test provides results in two to three days and Stanford Health Care can test 500 samples per day. Know what more it has to offer.
April 13, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 10, 2020.
April 10, 2020
 · 
7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 9, 2020.
April 9, 2020
 · 
9 min read
 · 
BioSpace Editorial Staff
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