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FDA

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Manufacturing
AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
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
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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
 · 
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
FDA
Calls for Leadership Stability and Rare Disease Follow-Through at FDA in 2026
January 5, 2026
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9 min read
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Tristan Manalac
FEATURED STORIES
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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
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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
 · 
Heather McKenzie
Checklist
Manufacturing
Big Pharma Pushes FDA To Decouple Inspections From Drug Approval Applications
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
December 16, 2025
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4 min read
 · 
Nick Paul Taylor
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THE LATEST
Policy
Biopharma Update on the Novel Coronavirus: August 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
August 6, 2020
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3 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves GSK’s Blenrep as Fourth-Line Multiple Myeloma Monotherapy Treatment
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.
August 6, 2020
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3 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.
August 4, 2020
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5 min read
 · 
BioSpace Editorial Staff
Gavreto is approved by FDA yet again.
FDA
FDA Approves MorphoSys and Incyte’s DLBCL Drug Monjuvi
Eight months after inking a collaboration deal, MorphoSys and Incyte won approval for Monjuvi for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
August 3, 2020
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2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August 3, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
July 30, 2020
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4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.
July 29, 2020
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5 min read
 · 
BioSpace Editorial Staff
Oxbryta gets greenlight for Pediatric SCD treatmen
FDA
FDA Greenlights Gilead/Kite’s Tecartus for Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
July 24, 2020
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3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 27, 2020.
July 24, 2020
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2 min read
 · 
BioSpace Editorial Staff
FDA
AstraZeneca Wins FDA Approval for COPD Treatment
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
July 24, 2020
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2 min read
 · 
Alex Keown
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