SUBSCRIBE
SUBSCRIBE
News

FDA

Rafael Henrique/SOPA Images/LightRocket via Getty
FDA
Bluebird Spreads Wings After Company Split; REGENXBIO Gets Orphan Nod
The FDA has granted Cambridge-based bluebird Bio a Priority Review of its Biologics License Application for betibeglogene autotemcel (beti-cel).
November 22, 2021
 · 
2 min read
 · 
Kate Goodwin
FDA
FDA Action Alert: Takeda, Aadi and Fennec
November 19, 2021
 · 
3 min read
 · 
Mark Terry
BioMarin HQ/courtesy of BioMarin
FDA
BioMarin Scores a First Day After Filing Trade Secrets Lawsuit
November 19, 2021
 · 
4 min read
 · 
Alex Keown
FDA
FDA Says COVID-19 Vaccine Boosters for All 18 Plus
November 19, 2021
 · 
2 min read
 · 
Heather McKenzie
Drug Development
New Mavacamten PDUFA Date Will Allow Further Risk Mitigation Review
November 19, 2021
 · 
2 min read
 · 
Vanessa Doctor, RN
FDA
Monoclonal Antibodies Shine in the Fight Against COVID-19
November 18, 2021
 · 
4 min read
 · 
Alex Keown
FDA
Merck Celebrates Another Win for Blockbuster Keytruda
November 18, 2021
 · 
2 min read
 · 
Mark Terry
FEATURED STORIES
Richard Pazdur
FDA
Makary Got His Man in Pazdur—But Can He Last as CDER Director?
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
November 18, 2025
 · 
6 min read
 · 
Heather McKenzie
A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.
Regulatory
Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
November 17, 2025
 · 
6 min read
 · 
Heather McKenzie
Opinion
How the FDA Is Accelerating Cell and Gene Therapy’s Next Chapter
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
November 14, 2025
 · 
6 min read
 · 
Anshul Mangal
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
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
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
Load More