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Drug Development
Merck’s Keytruda Notches Win in First-Line Cervical Cancer
Today’s approval was based on the Phase III KEYNOTE-826 trial that evaluated Keytruda and chemotherapy with or without bevacizumab compared to the same chemotherapy treatment.
October 14, 2021
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3 min read
 · 
Mark Terry
FDA
FDA Experts: Case is Inconclusive for Moderna Vaccine Booster
October 13, 2021
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2 min read
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Vanessa Doctor, RN
Jason Armond / Los Angeles Times via Getty Images
FDA
FDA Greenlights Enzyvant Drug Rethymic for Ultra-Rare Pediatric Disease
October 11, 2021
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3 min read
 · 
Mark Terry
Drug Development
Alzheimer’s Treatment Drug Granted FDA Breakthrough Designation as Space Heats Up
October 11, 2021
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2 min read
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Vanessa Doctor, RN
Drug Development
Moving Quickly, Merck Submits COVID-19 Antiviral for FDA Approval
October 11, 2021
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3 min read
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Mark Terry
FDA
FDA Finally Approves ChemoCentryx’s Tavneos for ANCA Vasculitis
October 8, 2021
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3 min read
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Mark Terry
Drug Development
Takeda Wins Unanimous Vote of Confidence for Refractory CMV Drug
October 8, 2021
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2 min read
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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
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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
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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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THE LATEST
Drug Development
Biopharma Update on the Novel Coronavirus: April 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.
April 21, 2020
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6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
April 20, 2020
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4 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Incyte’s Pemazyre for Rare Bile Duct Cancer
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
April 20, 2020
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3 min read
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Mark Terry
TARPEYO is the first FDA-approved drug for immunog
FDA
Seattle Genetics’ Tukysa Earns FDA Approval for HER2+ Breast Cancer
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
April 20, 2020
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3 min read
 · 
Mark Terry
FDA
FDA Action Alert: Sanofi, Neurocrine, Correvio and United
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
April 17, 2020
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3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 17, 2020.
April 17, 2020
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6 min read
 · 
BioSpace Editorial Staff
FDA
FDA Gives UroGen’s Jelmyto Expedited Approval for Urothelial Cancer
Jelmyto is the first and only non-surgical treatment for patients with this indication. Here’s everything you need to know about it.
April 16, 2020
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2 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020.
April 16, 2020
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8 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Use of Ortho’s High-Throughput, Automated COVID-19 Antibody Test
Antibody tests, also called serological tests, test if the individual has been exposed to SARS-CoV-2, the novel coronavirus that causes COVID-19.
April 15, 2020
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2 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
April 15, 2020
 · 
7 min read
 · 
BioSpace Editorial Staff
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