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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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THE LATEST
FDA
FDA Approves Use of Ortho’s High-Throughput, Automated COVID-19 Antibody Test
Antibody tests, also called serological tests, test if the individual has been exposed to SARS-CoV-2, the novel coronavirus that causes COVID-19.
April 15, 2020
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2 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
April 15, 2020
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7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 14, 2020.
April 14, 2020
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6 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Rutgers’ Saliva Test for COVID-19
The U.S. Food and Drug Administration granted emergency use authorization to Rutgers’ RUCDR Infinite Biologics for its test that uses saliva.
April 13, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 13, 2020.
April 13, 2020
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4 min read
 · 
BioSpace Editorial Staff
Stanford serology test is finally here.
FDA
Stanford Serology Test: Stanford Joins List of Organizations Offering COVID-19 Antibody Testing
The Stanford serology test provides results in two to three days and Stanford Health Care can test 500 samples per day. Know what more it has to offer.
April 13, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 10, 2020.
April 10, 2020
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7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 9, 2020.
April 9, 2020
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9 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Pfizer’s Braftovi Plus Cetuximab for Colorectal Cancer with BRAF Mutations
“We are pleased by the FDA’s approval of Braftovi in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.
April 9, 2020
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2 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 8, 2020.
April 8, 2020
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7 min read
 · 
BioSpace Editorial Staff
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