SUBSCRIBE
SUBSCRIBE
News

FDA

One red lottery winner or rare disease, multi-level personification, power, reverse search, secret sample, special spy, close-up. Company leader
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
 · 
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
 · 
1 min read
 · 
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
 · 
1 min read
 · 
Jef Akst
Approvals
Vera moves into growing kidney disease space with FDA’s accelerated IgAN nod
July 7, 2026
 · 
2 min read
 · 
Annalee Armstrong
Opinion
The FDA must put biotech at its center or continue to cede early research to China
July 6, 2026
 · 
4 min read
 · 
Kendalle Burlin O’Connell
FDA
Despite chaos and churn, FDA decisions hold mostly steady in H1 2026
July 6, 2026
 · 
8 min read
 · 
Tristan Manalac
Editorial
Biotech’s China problem: An issue of national security or economic value for the US?
July 2, 2026
 · 
6 min read
 · 
Jef Akst
FEATURED STORIES
3D. rocket soaring. Different rockets fly high and stand out. different from others, concept startup idea, new generation, faster work better
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
 · 
4 min read
 · 
Heather McKenzie
Business meeting concept as a group united together as a partnership symbol of strength.
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
 · 
4 min read
 · 
Heather McKenzie
Solution problem concept. Man walking on tightrope. Life coaching, transformation idea. Brainstorming in business. Vector illustration
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
 · 
6 min read
 · 
David Crean
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Oriahnn is the new non-surgical treatment for heav
FDA
FDA Approves New Treatment Oriahnn for Heavy Menstrual Bleeding Associated with Uterine Fibroids
AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
June 1, 2020
 · 
2 min read
 · 
Alex Keown
FDA
Genentech’s Tecentriq-Avastin Combo Approved for HCC, an Improvement on Standard of Care
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
June 1, 2020
 · 
3 min read
 · 
Mark Terry
FDA
FDA Approves Lilly’s Tauvid Imaging Agent to Help Diagnose Alzheimer’s Disease
Tauvid is the first and only approved diagnostic agent for imaging tau neurofibrillary tangles (NFTs) in the brain.
May 29, 2020
 · 
3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: June 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 1, 2020.
May 28, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 29, 2020.
May 28, 2020
 · 
2 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 28, 2020.
May 28, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 27, 2020.
May 27, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
FDA
BMS’ Opdivo and Yervoy Combination Treatment Snags Two Approvals in Lung Cancer this Month
Bristol Myers Squibb is doing its best to claim market share in the checkpoint inhibitor space and over the past month, the company is pushing its way forward with a pair of regulatory approvals in lung cancer.
May 27, 2020
 · 
2 min read
 · 
Alex Keown
FDA
Sanofi and Regeneron’s Dupixent Scores Another Approval for Dermatitis, This Time in Kids
To date, Dupixent is the only biologic approved for this age group.
May 26, 2020
 · 
3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 26, 2020.
May 26, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Load More