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FDA
1 in 5 Americans Have had COVID-19, Veklury Approved in New Indication
It’s a landmark no one expected or wanted — more than 70 million confirmed COVID-19 cases in the U.S. with 866,000 deaths. For that and more COVID-19 news, continue reading.
January 24, 2022
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6 min read
 · 
Mark Terry
SKYRIZI is the new option for psoriatic arthritis.
Drug Development
AbbVie’s SKYRIZI Offers New Option for Psoriatic Arthritis Sufferers
January 24, 2022
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2 min read
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Vanessa Doctor, RN
FDA
Early Immunotherapy for Peanut Allergies Shows Potential in Toddlers
January 21, 2022
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2 min read
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Hayley Shasteen
Drug Development
Kura Sees Quick Resolution as FDA Lifts AML Study Hold
January 21, 2022
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2 min read
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Vanessa Doctor, RN
Drug Development
AbbVie’s Rinvoq Racks Up Expanded Win In Atopic Dermatitis
January 17, 2022
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2 min read
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Alex Keown
Drug Development
Another Atopic Dermatitis Drug Hits the Market as FDA Okays Pfizer’s Cibinqo
January 17, 2022
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3 min read
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Mark Terry
FDA
Newly Discovered Gene Doubles Severe COVID-19 Risk and WHO Updates Guidelines
January 14, 2022
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5 min read
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Mark Terry
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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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Editorial
FDA’s Bad Rap: Pazdur Steps Up as Agency Continues To Take on Water
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
November 13, 2025
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8 min read
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Jef Akst
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Policy
Biopharma Update on the Novel Coronavirus: September 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
September 16, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.
September 14, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.
September 10, 2020
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2 min read
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BioSpace Editorial Staff
Treatment of asthma coming very soon.
FDA
GSK’s Trelegy Ellipta Wins Approval as Treatment of Asthma
GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. Here’s what you need to learn.
September 10, 2020
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2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: September 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
September 8, 2020
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4 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
September 3, 2020
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3 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves New HIV-1/HIV-2 Qualitative Test from Roche
This test will give healthcare providers a single result to confirm an HIV diagnosis with patients and differentiate between HIV-1 and HIV-2.
September 2, 2020
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2 min read
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Krystle Vermes
Drug Development
At Least 4 Vaccine Candidates Backed by U.S. Government Predicted to Fail, Analytics Group Says
The U.S. government has financially backed the development of six different vaccine candidates aimed at the novel coronavirus. Although billions of dollars have been appropriated to the pandemic, at least four of those potential preventative treatments are predicted to fail in the clinic.
September 2, 2020
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3 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: September 2
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 2, 2020.
September 1, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: August 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 31, 2020.
August 31, 2020
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2 min read
 · 
BioSpace Editorial Staff
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