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Approvals
Sentynl, Fortress Bounce Back With FDA Approval for Rare Pediatric Disease
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
January 13, 2026
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2 min read
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Tristan Manalac
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Manufacturing
AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules
January 13, 2026
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5 min read
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Nick Paul Taylor
a robotic assembly line with vials
Regulatory
FDA Carves Out Manufacturing Exemptions for CGTs To Accelerate Development
January 12, 2026
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2 min read
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Tristan Manalac
FDA
6 FDA Decisions To Watch in Q1 2026
January 12, 2026
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8 min read
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Tristan Manalac
Complete response letters
Vanda Slides After FDA Again Rejects Hetlioz For Jet Lag
January 8, 2026
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2 min read
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Dan Samorodnitsky
Multiple sclerosis
Sanofi’s MS Drug Tripped Up by Toxicities, Unclear Benefit, Rejection Letter Reveals
January 6, 2026
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3 min read
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Tristan Manalac
FDA
FDA Went Against Adcomm Votes More, Held Fewer Meetings in 2025
January 6, 2026
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3 min read
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Heather McKenzie
FEATURED STORIES
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FDA
Calls for Leadership Stability and Rare Disease Follow-Through at FDA in 2026
After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
January 5, 2026
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9 min read
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Tristan Manalac
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Opinion
Addressing the Regulatory Reality of Replacing In Vivo Models in Drug Development
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
January 5, 2026
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6 min read
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Xiaoxia Li
Digital compass. Business strategic explorer, Vision crisis, Mission path, Agency creative, Digital strategy, Market decision, Achievement strategy, Financial stock, Company vision concepts
FDA
FDA Policy Tracker: 2025 Was a Year of Change
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
December 22, 2025
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13 min read
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Heather McKenzie
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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
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2 min read
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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
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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
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2 min read
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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
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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
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6 min read
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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
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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
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4 min read
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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
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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
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9 min read
 · 
BioSpace Editorial Staff
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