SUBSCRIBE
SUBSCRIBE
News

FDA

Female hand showing thumbs up gesture on blue background, art collage. Positive hand sign. Fashion collage in the style of Thumbs up magazine. Contemporary art. Modern design.
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
 · 
2 min read
 · 
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
 · 
5 min read
 · 
Nick Paul Taylor
a robotic assembly line with vials
Regulatory
FDA Carves Out Manufacturing Exemptions for CGTs To Accelerate Development
January 12, 2026
 · 
2 min read
 · 
Tristan Manalac
FDA
6 FDA Decisions To Watch in Q1 2026
January 12, 2026
 · 
8 min read
 · 
Tristan Manalac
Complete response letters
Vanda Slides After FDA Again Rejects Hetlioz For Jet Lag
January 8, 2026
 · 
2 min read
 · 
Dan Samorodnitsky
Multiple sclerosis
Sanofi’s MS Drug Tripped Up by Toxicities, Unclear Benefit, Rejection Letter Reveals
January 6, 2026
 · 
3 min read
 · 
Tristan Manalac
FDA
FDA Went Against Adcomm Votes More, Held Fewer Meetings in 2025
January 6, 2026
 · 
3 min read
 · 
Heather McKenzie
FEATURED STORIES
Doubtful person, hands on hips, choosing the way as multiple arrows on the road showing a mess of different directions. Choosing the correct pathway, difficult decision concept, confusion symbol.
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
 · 
9 min read
 · 
Tristan Manalac
Bilogical genetic engineering research at laboratory, vector illustration. Doctor conduct experiment with mouse, study dna genes. Scientist near large animal and screen with work analysis.
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
 · 
6 min read
 · 
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
 · 
13 min read
 · 
Heather McKenzie
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
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
Kynmobi got approved stamp from FDA
FDA
FDA Gives Thumbs-Up to Sunovion’s Under-the-Tongue Parkinson’s Drug Kynmobi
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.
May 22, 2020
 · 
3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: May 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 22, 2020.
May 22, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
May 21, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
May 20, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
FDA
Lynparza Becomes Second PARP Inhibitor Approved for Prostate Cancer, Just Days Behind the First
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
May 20, 2020
 · 
3 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 19, 2020.
May 19, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
FDA
FDA Grants Genentech’s Checkpoint Inhibitor Tecentriq Another NSCLC Approval
The approval was based on interim analysis from the company’s Phase III IMpower110 trial.
May 19, 2020
 · 
2 min read
 · 
Mark Terry
FDA
Clovis Oncology’s PARP Inhibitor Rubraca Gets Greenlight from FDA in Prostate Cancer
With the new approval, Rubraca becomes the first PARP inhibitor approved in a prostate cancer setting.
May 18, 2020
 · 
2 min read
 · 
Alex Keown
Load More