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FDA

Drug Development
Incyte on a Roll with Two FDA Wins in Two Days
The approval is based on its Phase III REACH3 trial, which evaluated Jakafi versus the best available therapy for treating chronic GVHD after allogeneic stem cell transplantation.
September 23, 2021
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2 min read
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Vanessa Doctor, RN
FDA
FDA Gives Narrow Authorization for Pfizer-BioNTech Booster
September 22, 2021
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4 min read
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Mark Terry
Eyesonmilan / Shutterstock
FDA
New Atopic Dermatitis Option Available as FDA Approves Incyte’s Opzelura
September 22, 2021
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3 min read
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Mark Terry
Drug Development
Breakthrough Cervical Cancer Treatment Wins Accelerated FDA Approval
September 21, 2021
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2 min read
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Vanessa Doctor, RN
FDA
FDA Slaps Down Verrica’s Skin Disease Treatment Over Quality Concerns at CMO
September 21, 2021
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2 min read
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Alex Keown
FDA
Biogen and Samsung Bioepis Heat Up the Lucrative AMD Market with First Biosimilar Approval
September 20, 2021
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2 min read
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Kate Goodwin
FDA
COVID-19 Update: Vaccines for Kids and an Upcoming Verdict on Boosters
September 16, 2021
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3 min read
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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
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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: April 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 3, 2020.
April 3, 2020
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6 min read
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BioSpace Editorial Staff
FDA
FDA Approves 1st COVID-19 Antibody Test
The U.S. Food and Drug Administration approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19.
April 3, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 1, 2020.
April 1, 2020
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8 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: March 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 31, 2020.
March 31, 2020
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7 min read
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BioSpace Editorial Staff
FDA
Amidst Controversy, FDA Issues EUA Allowing Anti-Malaria Drugs to Be Used to Treat COVID-19
Scientists and physicians have been cautious about use of the drug for the disease, while President Trump touted it as a “game changer.”
March 30, 2020
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4 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: March 30
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 30, 2020.
March 30, 2020
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5 min read
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BioSpace Editorial Staff
FDA
Abbott’s Point-of-Care COVID-19 Test Detects Coronavirus in as Little as 5 Minutes
Abbott’s new point-of-care test for the novel coronavirus that causes COVID-19 was approved by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA).
March 28, 2020
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4 min read
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Mark Terry
Drug Development
Biopharma Industry News for March 27: Update on the Novel Coronavirus
A summary of daily biopharma industry news. Please check out stories that are trending on March 27, 2020.
March 27, 2020
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3 min read
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BioSpace Editorial Staff
nitpicker / Shutterstock
FDA
BMS’ Ozanimod Wins FDA Approval for Relapsing Multiple Sclerosis
Although Zeposia has now been approved in the United States, BMS said it was delaying commercialization due to the “unprecedented COVID-19 pandemic.”
March 26, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Industry News for March 26: Update on the Novel Coronavirus
A summary of daily biopharma industry news. Please check out stories that are trending on March 26, 2020.
March 26, 2020
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5 min read
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BioSpace Editorial Staff
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