SUBSCRIBE
SUBSCRIBE
News

FDA

Drug Development
FDA Authorizes Second Oral Antiviral for COVID-19
The FDA has greenlit Merck and Ridgeback’s molnupiravir under EUA to treat mild to moderate COVID-19 infections in adults at high risk of progression to severe disease.
December 23, 2021
 · 
3 min read
 · 
Alex Keown
Harold Cunningham/Getty Images
Drug Development
Novartis Drug Approved for Juvenile ERA and Psoriatic Arthritis
December 23, 2021
 · 
2 min read
 · 
Alex Keown
FDA
New Drug Approved for Lowering Bad Cholesterol
December 23, 2021
 · 
2 min read
 · 
Vanessa Doctor, RN
FDA
FDA Authorizes First Oral COVID Antiviral Drug
December 22, 2021
 · 
3 min read
 · 
Mark Terry
Drug Development
Takeda Stumbles to be First EoE Treatment to Market Following FDA CRL
December 22, 2021
 · 
2 min read
 · 
Alex Keown
Drug Development
DBV Continues to Fight for Viaskin Peanut, Initiates New Phase III Study after FDA Rejection
December 22, 2021
 · 
2 min read
 · 
Alex Keown
Drug Development
FDA Approves First and Only Injectable to Prevent HIV Infection
December 21, 2021
 · 
3 min read
 · 
Vanessa Doctor, RN
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
Policy
Biopharma Update on the Novel Coronavirus: August 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August 3, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
July 30, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.
July 29, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
Oxbryta gets greenlight for Pediatric SCD treatmen
FDA
FDA Greenlights Gilead/Kite’s Tecartus for Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
July 24, 2020
 · 
3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 27, 2020.
July 24, 2020
 · 
2 min read
 · 
BioSpace Editorial Staff
FDA
AstraZeneca Wins FDA Approval for COPD Treatment
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
July 24, 2020
 · 
2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 24, 2020.
July 23, 2020
 · 
4 min read
 · 
Editorial Staff
FDA
Jazz Pharma Wins FDA Approval for Lower-Sodium Narcolepsy Treatment
The U.S. Food and Drug Administration (FDA) approved Xywav, the first new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
July 22, 2020
 · 
2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 22, 2020.
July 21, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 20, 2020.
July 20, 2020
 · 
2 min read
 · 
BioSpace Editorial Staff
Load More