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Rare diseases
Through flux and fluidity, FDA keeps coming back to rare disease
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
July 8, 2026
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6 min read
 · 
Heather McKenzie
Vector illustration. Product recall.
Manufacturing
Amgen recalls almost 1 million bottles of heart failure drug over quality issue
July 8, 2026
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1 min read
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Nick Paul Taylor
Podcast
Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil
July 8, 2026
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1 min read
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Jef Akst
Approvals
Vera moves into growing kidney disease space with FDA’s accelerated IgAN nod
July 7, 2026
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2 min read
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Annalee Armstrong
Opinion
The FDA must put biotech at its center or continue to cede early research to China
July 6, 2026
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4 min read
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Kendalle Burlin O’Connell
FDA
Despite chaos and churn, FDA decisions hold mostly steady in H1 2026
July 6, 2026
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8 min read
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Tristan Manalac
Editorial
Biotech’s China problem: An issue of national security or economic value for the US?
July 2, 2026
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6 min read
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Jef Akst
FEATURED STORIES
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Huntington’s disease
Skyhawk CEO hopes FDA’s new uniQure position will translate to Huntington’s pill
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
June 30, 2026
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4 min read
 · 
Heather McKenzie
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Duchenne muscular dystrophy
Capricor thrown for another loop as FDA sets adcomm for DMD cardiomyopathy therapy
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
June 26, 2026
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4 min read
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Heather McKenzie
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Opinion
The hidden cost of FDA unpredictability
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
June 26, 2026
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6 min read
 · 
David Crean
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Policy
Biopharma Update on the Novel Coronavirus: September 25
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 25, 2020.
September 22, 2020
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4 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 23, 2020.
September 22, 2020
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5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.
September 21, 2020
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2 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
September 17, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
September 16, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.
September 14, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.
September 10, 2020
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2 min read
 · 
BioSpace Editorial Staff
Treatment of asthma coming very soon.
FDA
GSK’s Trelegy Ellipta Wins Approval as Treatment of Asthma
GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. Here’s what you need to learn.
September 10, 2020
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2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: September 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
September 8, 2020
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4 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
September 3, 2020
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3 min read
 · 
BioSpace Editorial Staff
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