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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
 · 
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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Drug Development
Biopharma Update on the Novel Coronavirus: May 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 11, 2020.
May 11, 2020
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4 min read
 · 
BioSpace Editorial Staff
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FDA
FDA Approves Eli Lilly’s Precision Oncology Treatment Retevmo for Certain Lung and Thyroid Cancers
Eli Lilly is moving quickly to get a newly-approved precision oncology treatment, Retevmo, for certain lung and thyroid cancers into the hands of patients.
May 11, 2020
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3 min read
 · 
Alex Keown
FDA
FDA Grants Emergency Use Authorization for Rutgers’ At-Home COVID-19 Saliva Test
The new at-home saliva self-collection assay allows for broader screening than the standard and uncomfortable method using nose and throat swabs at a healthcare facility or testing location that requires a physical interaction with a healthcare professional.
May 8, 2020
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2 min read
 · 
Alex Keown
FDA
FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here’s a look at what’s on the schedule for the next two weeks.
May 8, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 8, 2020.
May 8, 2020
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5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 7, 2020.
May 7, 2020
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5 min read
 · 
BioSpace Editorial Staff
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FDA
Tabrecta: FDA Gives Novartis Approval for First-Ever Therapy for NSCLC Tumors with METex14
Developed by Novartis, the drug, Tabrecta, is designed for a type of NSCLC that has spread to other parts of the body and cannot be removed by surgery.
May 6, 2020
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4 min read
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Gail Dutton
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FDA
FDA Approves AstraZeneca’s Farxiga for Heart Failure in Adults with Reduced Ejection Fraction
The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.
May 6, 2020
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3 min read
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Krystle Vermes
Policy
Biopharma Update on the Novel Coronavirus: May 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 6, 2020.
May 6, 2020
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5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 5, 2020.
May 5, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
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