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FDA

Drug Development
FDA Approves First and Only Injectable to Prevent HIV Infection
ViiV Healthcare announced that the FDA approved Apretude, a long-acting injectable pre-exposure prophylactic option to reduce the risk of sexually acquired HIV-1.
December 21, 2021
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3 min read
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Vanessa Doctor, RN
FDA
A Look at the Biggest Biopharma Stories of 2021
December 20, 2021
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6 min read
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Mark Terry
FDA
There’s a New Humira Challenger as Coherus Biosimilar Wins Approval
December 20, 2021
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2 min read
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Alex Keown
FDA
Schizophrenia Drug CAPLYTA Snags Second Approval for Bipolar Depression
December 20, 2021
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2 min read
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Kate Goodwin
FDA
Argenx’s Regulatory Milestone Offers New Hope for gMG Patients
December 20, 2021
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3 min read
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Sreetama Dutt
Drug Development
10 Biggest Novel Drug Approvals of 2021
December 19, 2021
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6 min read
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Mark Terry
FDA
Global Blood Therapeutics’ Oxbryta Greenlit for Pediatric SCD Patients Ages 4 to 11
December 17, 2021
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2 min read
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Alex Keown
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
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6 min read
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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
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6 min read
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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
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6 min read
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Anshul Mangal
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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
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2 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 17, 2020.
July 16, 2020
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5 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 15, 2020.
July 14, 2020
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5 min read
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BioSpace Editorial Staff
FDA
Janssen’s Tremfya Snags Approval as First IL-23 Treatment for Active Psoriatic Arthritis
In announcing the approval this morning, Janssen said IL-23 is a naturally occurring cytokine involved in normal inflammatory and immune responses associated with symptoms of psoriatic arthritis.
July 14, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 10, 2020.
July 9, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 8, 2020.
July 7, 2020
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5 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 6, 2020.
July 6, 2020
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2 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.
July 2, 2020
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1 min read
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BioSpace Editorial Staff
FDA gave green signal to Beigene's Brukinsa after
FDA
FDA Gives Pfizer and Merck KGaA’s Bavencio a Thumbs-Up for Urothelial Cancer
Bavencio is an anti-PD-L1 checkpoint inhibitor co-developed by Merck KGaA, Darmstadt, German and Pfizer via EMD Serono, a business unit of the two companies.
July 1, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: July 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 1, 2020.
June 30, 2020
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3 min read
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BioSpace Editorial Staff
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