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Gene therapy
FDA approval of Regeneron’s hearing loss gene therapy breaks barriers
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
April 23, 2026
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4 min read
 · 
Heather McKenzie
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Manufacturing
FDA issues warning letter after GLP-1 manufacturer refuses inspectors access
April 22, 2026
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2 min read
 · 
Nick Paul Taylor
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Psychedelics
Trump’s psychedelics push a mixed blessing for neuropsychiatric companies, patients
April 22, 2026
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8 min read
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Heather McKenzie
Approvals
Merck steps up as ‘meaningful competitor’ to Gilead with HIV pill approval
April 22, 2026
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1 min read
 · 
Tristan Manalac
Policy
FDA Policy Tracker 2026: Psychedelics get a boost
April 20, 2026
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10 min read
 · 
BioSpace Editorial Staff
FDA
Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA
April 17, 2026
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5 min read
 · 
Heather McKenzie
FDA
Drug pricing watchdog calls for increased transparency into FDA’s accelerated approval decisions
April 16, 2026
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4 min read
 · 
Heather McKenzie
FEATURED STORIES
FDA
Deep dive: Checking in with the FDA
BioSpace looks back at 2025 and where the FDA is going in 2026.
April 15, 2026
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2 min read
 · 
Heather McKenzie
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Regulatory
FDA flexibility isn’t absent but evolving regulations come with growing pains
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
April 13, 2026
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5 min read
 · 
Heather McKenzie
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FDA
FDA’s CRL transparency policy is boosting biopharma accountability
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
April 13, 2026
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5 min read
 · 
Nick Paul Taylor
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THE LATEST
Drug Development
Biopharma Update on the Novel Coronavirus: September 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 28, 2020.
September 22, 2020
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2 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 25
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 25, 2020.
September 22, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 23, 2020.
September 22, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.
September 21, 2020
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2 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
September 17, 2020
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3 min read
 · 
BioSpace Editorial Staff
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
 · 
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
 · 
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
 · 
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
 · 
4 min read
 · 
BioSpace Editorial Staff
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