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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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Drug Development
Biopharma Update on the Novel Coronavirus: April 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
April 23, 2020
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5 min read
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BioSpace Editorial Staff
Chronic lymphocytic leukemia
FDA
Imbruvica-Rituximab Combo Approved by FDA for Chronic Lymphocytic Leukemia
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
April 22, 2020
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2 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
April 22, 2020
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5 min read
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BioSpace Editorial Staff
FDA
LabCorp’s COVID-19 At-Home Test Kit Approved for Emergency Use
It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.
April 21, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.
April 21, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
April 20, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Incyte’s Pemazyre for Rare Bile Duct Cancer
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
April 20, 2020
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3 min read
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Mark Terry
TARPEYO is the first FDA-approved drug for immunog
FDA
Seattle Genetics’ Tukysa Earns FDA Approval for HER2+ Breast Cancer
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
April 20, 2020
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3 min read
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Mark Terry
FDA
FDA Action Alert: Sanofi, Neurocrine, Correvio and United
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
April 17, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 17, 2020.
April 17, 2020
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6 min read
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BioSpace Editorial Staff
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