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FDA

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Opinion
Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
April 24, 2026
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5 min read
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Joshua R. Mansbach
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Gene therapy
FDA approval of Regeneron’s hearing loss gene therapy breaks barriers
April 23, 2026
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4 min read
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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
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Nick Paul Taylor
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
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Tristan Manalac
Policy
FDA Policy Tracker 2026: Psychedelics get a boost
April 20, 2026
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10 min read
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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
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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
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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
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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
FDA
FDA Delays Ruling on Novartis’ Relapsing Multiple Sclerosis Drug Arzerra
On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months.
June 3, 2020
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2 min read
 · 
Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 3, 2020.
June 3, 2020
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4 min read
 · 
BioSpace Editorial Staff
Oriahnn is the new non-surgical treatment for heav
FDA
FDA Approves New Treatment Oriahnn for Heavy Menstrual Bleeding Associated with Uterine Fibroids
AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
June 1, 2020
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2 min read
 · 
Alex Keown
FDA
Genentech’s Tecentriq-Avastin Combo Approved for HCC, an Improvement on Standard of Care
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
June 1, 2020
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3 min read
 · 
Mark Terry
FDA
FDA Approves Lilly’s Tauvid Imaging Agent to Help Diagnose Alzheimer’s Disease
Tauvid is the first and only approved diagnostic agent for imaging tau neurofibrillary tangles (NFTs) in the brain.
May 29, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: June 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 1, 2020.
May 28, 2020
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3 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 29, 2020.
May 28, 2020
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2 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 28, 2020.
May 28, 2020
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6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 27, 2020.
May 27, 2020
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4 min read
 · 
BioSpace Editorial Staff
FDA
BMS’ Opdivo and Yervoy Combination Treatment Snags Two Approvals in Lung Cancer this Month
Bristol Myers Squibb is doing its best to claim market share in the checkpoint inhibitor space and over the past month, the company is pushing its way forward with a pair of regulatory approvals in lung cancer.
May 27, 2020
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2 min read
 · 
Alex Keown
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