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Manufacturing
CDMOs Pin Hopes for Accelerating Uptake at New US Sites on FDA’s PreCheck Program
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies including Novo Nordisk see hurdles to implementing the changes.
January 20, 2026
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4 min read
 · 
Nick Paul Taylor
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FDA
JPM26: Beam, Cabaletta, More Zero In on Regulatory Alignment After Tumultuous Year
January 19, 2026
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6 min read
 · 
Heather McKenzie
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FDA
FDA Delays Decision for Lilly’s Obesity Pill Orforglipron, Other Priority Voucher Awardees: Report
January 15, 2026
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2 min read
 · 
Tristan Manalac
GLP-1
FDA Asks Novo, Lilly To Remove Suicide Warnings From GLP-1 Weight Loss Products
January 14, 2026
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1 min read
 · 
Tristan Manalac
Approvals
Sentynl, Fortress Bounce Back With FDA Approval for Rare Pediatric Disease
January 13, 2026
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2 min read
 · 
Tristan Manalac
Manufacturing
AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules
January 13, 2026
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5 min read
 · 
Nick Paul Taylor
Regulatory
FDA Carves Out Manufacturing Exemptions for CGTs To Accelerate Development
January 12, 2026
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2 min read
 · 
Tristan Manalac
FEATURED STORIES
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FDA
6 FDA Decisions To Watch in Q1 2026
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.
January 12, 2026
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8 min read
 · 
Tristan Manalac
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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
 · 
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
 · 
Xiaoxia Li
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