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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: July 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 10, 2020.
July 9, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 8, 2020.
July 7, 2020
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5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 6, 2020.
July 6, 2020
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2 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.
July 2, 2020
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1 min read
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BioSpace Editorial Staff
FDA gave green signal to Beigene's Brukinsa after
FDA
FDA Gives Pfizer and Merck KGaA’s Bavencio a Thumbs-Up for Urothelial Cancer
Bavencio is an anti-PD-L1 checkpoint inhibitor co-developed by Merck KGaA, Darmstadt, German and Pfizer via EMD Serono, a business unit of the two companies.
July 1, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: July 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 1, 2020.
June 30, 2020
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3 min read
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BioSpace Editorial Staff
FDA
Merck’s Keytruda Approved for First-Line Treatment of Colorectal Cancer
The anti-PD-1 therapy was approved by the U.S. Food and Drug Administration alone for first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
June 30, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: June 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 29, 2020.
June 29, 2020
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2 min read
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BioSpace Editorial Staff
Abicipar pegol rejected by FDA
FDA
Allergan/AbbVie’s Macular Degeneration Drug Abicipar Pegol Rejected by FDA
The U.S. Food and Drug Administration issued a Complete Response Letter, a rejection, of Allergan’s Biologics License Application for Abicipar pegol for neovascular age-related macular degeneration.
June 26, 2020
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3 min read
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Mark Terry
FDA
Zogenix Wins Approval for Dravet Syndrome Treatment Fintepla
Shares of Zogenix were up more than 16% in premarket trading following the regulatory approval of the epilepsy drug Fintepla for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy, in patients ages two and above.
June 26, 2020
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2 min read
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Alex Keown
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