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FDA

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FDA
Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
February 13, 2026
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6 min read
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Heather McKenzie
FDA
FDA’s Prasad Weathers Personal Controversy, Internal Strife Amid Moderna Imbroglio
February 12, 2026
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2 min read
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Dan Samorodnitsky
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Editorial
All the Ways Moderna’s Flu Vaccine Rejection Letter Shocked Us
February 11, 2026
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4 min read
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Dan Samorodnitsky
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
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
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: May 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 27, 2020.
May 27, 2020
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4 min read
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BioSpace Editorial Staff
FDA
BMS’ Opdivo and Yervoy Combination Treatment Snags Two Approvals in Lung Cancer this Month
Bristol Myers Squibb is doing its best to claim market share in the checkpoint inhibitor space and over the past month, the company is pushing its way forward with a pair of regulatory approvals in lung cancer.
May 27, 2020
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2 min read
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Alex Keown
FDA
Sanofi and Regeneron’s Dupixent Scores Another Approval for Dermatitis, This Time in Kids
To date, Dupixent is the only biologic approved for this age group.
May 26, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 26, 2020.
May 26, 2020
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4 min read
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BioSpace Editorial Staff
Kynmobi got approved stamp from FDA
FDA
FDA Gives Thumbs-Up to Sunovion’s Under-the-Tongue Parkinson’s Drug Kynmobi
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.
May 22, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: May 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 22, 2020.
May 22, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
May 21, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
May 20, 2020
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6 min read
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BioSpace Editorial Staff
FDA
Lynparza Becomes Second PARP Inhibitor Approved for Prostate Cancer, Just Days Behind the First
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
May 20, 2020
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3 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 19, 2020.
May 19, 2020
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4 min read
 · 
BioSpace Editorial Staff
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