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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
FDA signage at its headquarters in Maryland
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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Policy
Biopharma Update on the Novel Coronavirus: May 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 18, 2020.
May 18, 2020
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5 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 15, 2020.
May 15, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 14, 2020.
May 14, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 13, 2020.
May 13, 2020
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3 min read
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BioSpace Editorial Staff
FDA approved Ascendis Pharma’s Skytrofa.
FDA
Report: NDA, BLA Approvals by the FDA Fell 16% in 2019
A new report released on Tuesday by GlobalData suggested that there was a 16% decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration last year.
May 12, 2020
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2 min read
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Krystle Vermes
Drug Development
Biopharma Update on the Novel Coronavirus: May 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020.
May 12, 2020
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3 min read
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BioSpace Editorial Staff
FDA
Abbott Earns Emergency Use Authorization for Another COVID-19 Antibody Test
Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them.
May 11, 2020
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2 min read
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Alex Keown
TARPEYO is the first FDA-approved drug for immunog
FDA
AstraZeneca and Merck’s Lynparza Approved For Ovarian Cancer Just a Week After GSK’s Zejula
The Lynparza approval isn’t as broad as the Zejula approval, with Lynparza not approved for use in patients with homologous recombination deficiencies.
May 11, 2020
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3 min read
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Mark Terry
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
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BioSpace Editorial Staff
Jonathan Weiss/Shutterstock
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
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Alex Keown
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