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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
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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: April 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 7, 2020.
April 7, 2020
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6 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 6, 2020.
April 6, 2020
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6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 3, 2020.
April 3, 2020
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6 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves 1st COVID-19 Antibody Test
The U.S. Food and Drug Administration approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19.
April 3, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 1, 2020.
April 1, 2020
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8 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: March 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 31, 2020.
March 31, 2020
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7 min read
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BioSpace Editorial Staff
FDA
Amidst Controversy, FDA Issues EUA Allowing Anti-Malaria Drugs to Be Used to Treat COVID-19
Scientists and physicians have been cautious about use of the drug for the disease, while President Trump touted it as a “game changer.”
March 30, 2020
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4 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: March 30
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 30, 2020.
March 30, 2020
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5 min read
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BioSpace Editorial Staff
FDA
Abbott’s Point-of-Care COVID-19 Test Detects Coronavirus in as Little as 5 Minutes
Abbott’s new point-of-care test for the novel coronavirus that causes COVID-19 was approved by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA).
March 28, 2020
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4 min read
 · 
Mark Terry
Drug Development
Biopharma Industry News for March 27: Update on the Novel Coronavirus
A summary of daily biopharma industry news. Please check out stories that are trending on March 27, 2020.
March 27, 2020
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3 min read
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BioSpace Editorial Staff
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