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FDA
COVID News: J&J Booster Hopes, Waning Immunity, Anti-Vax Paper Retracted and More
There is — still — plenty of news about COVID-19 and new drugs, therapies and FDA applications. Here’s a look.
October 5, 2021
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4 min read
 · 
Mark Terry
Leon Neal/Getty Images
Drug Development
AstraZeneca’s Enhertu on a Roll with Fourth Breakthrough Therapy Designation
October 4, 2021
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2 min read
 · 
Vanessa Doctor, RN
FDA
FDA Action Alert: Takeda, ChemoCentryx, Genmab and Seagen, and Avadel
October 1, 2021
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4 min read
 · 
Mark Terry
Drug Development
Mirum Snags First Approval for LIVMARLI Drug for Treating Rare, Genetic Liver Disorder
September 30, 2021
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2 min read
 · 
Vanessa Doctor, RN
Drug Development
New Relief for Migraine Sufferers as FDA Approves AbbVie’s Atogepant
September 29, 2021
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2 min read
 · 
Alex Keown
FDA
FDA Action Alert: Mirum and Kite/Gilead
September 25, 2021
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3 min read
 · 
Mark Terry
FDA
CDC Breaks with Advisory Panel on Boosters, Recommends Broader Access
September 24, 2021
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4 min read
 · 
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
 · 
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
 · 
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
 · 
Anshul Mangal
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THE LATEST
Drug Development
Biopharma Update on the Novel Coronavirus: April 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 14, 2020.
April 14, 2020
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6 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Rutgers’ Saliva Test for COVID-19
The U.S. Food and Drug Administration granted emergency use authorization to Rutgers’ RUCDR Infinite Biologics for its test that uses saliva.
April 13, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 13, 2020.
April 13, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Stanford serology test is finally here.
FDA
Stanford Serology Test: Stanford Joins List of Organizations Offering COVID-19 Antibody Testing
The Stanford serology test provides results in two to three days and Stanford Health Care can test 500 samples per day. Know what more it has to offer.
April 13, 2020
 · 
3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 10, 2020.
April 10, 2020
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7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 9, 2020.
April 9, 2020
 · 
9 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Pfizer’s Braftovi Plus Cetuximab for Colorectal Cancer with BRAF Mutations
“We are pleased by the FDA’s approval of Braftovi in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.
April 9, 2020
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2 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 8, 2020.
April 8, 2020
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7 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 7, 2020.
April 7, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 6, 2020.
April 6, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
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