SUBSCRIBE
SUBSCRIBE
News

FDA

FDA
Studies Continue to Suggest Milder Omicron; FDA Pauses Domestic Drug Inspections
Evidence continues to accumulate suggesting that Omicron, although significantly more infectious than previous COVID-19 strains, causes less severe disease.
January 5, 2022
 · 
3 min read
 · 
Mark Terry
Pictured: FDA sign at headquarters/Courtesy of Get
Drug Development
FDA Lifts 11-Month Hold on Spero’s Lung Disease Drug
January 4, 2022
 · 
3 min read
 · 
Mark Terry
Drug Development
Spero, CStone Among First to Score NDA Approvals This Year
January 3, 2022
 · 
2 min read
 · 
Vanessa Doctor, RN
Drug Development
Applied Therapeutics Hits Bump After FDA Requests More Data for NDA
January 3, 2022
 · 
2 min read
 · 
Alex Keown
FDA
FDA Wraps Up 2021 with One Last Approval and Mesoblast Meeting
January 3, 2022
 · 
2 min read
 · 
Mark Terry
Drug Development
Will Novavax Vaccine for COVID-19 be able Cross the Finish Line in 2022?
January 3, 2022
 · 
2 min read
 · 
Alex Keown
Drug Development
FDA Approves New Skin-Clearing Drug for Atopic Dermatitis
December 28, 2021
 · 
2 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 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 17, 2020.
August 17, 2020
 · 
2 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: August 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 14, 2020.
August 13, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
Duchenne Muscular Dystrophy
FDA
FDA Approves NS Pharma’s Viltepso for Duchenne Muscular Dystrophy
The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).
August 13, 2020
 · 
3 min read
 · 
Mark Terry
Maxigesic IV on hold until FDA gets clarity on the
FDA
FDA Approves Trevena’s IV Opioid Olinvyk for Short-Term Acute Pain Management
Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.
August 13, 2020
 · 
2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 12, 2020.
August 11, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
FDA
Genentech Joins Biogen and Novartis in the Spinal Muscular Atrophy Market
Genentech, a Roche company, announced the U.S. Food and Drug Administration (FDA) had approved its Evrysdi (risdiplam) for spinal muscular atrophy (SMA) in adults and children two months of age and older.
August 10, 2020
 · 
4 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: August 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
August 6, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves GSK’s Blenrep as Fourth-Line Multiple Myeloma Monotherapy Treatment
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.
August 6, 2020
 · 
3 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.
August 4, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
Gavreto is approved by FDA yet again.
FDA
FDA Approves MorphoSys and Incyte’s DLBCL Drug Monjuvi
Eight months after inking a collaboration deal, MorphoSys and Incyte won approval for Monjuvi for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
August 3, 2020
 · 
2 min read
 · 
Alex Keown
Load More