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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
 · 
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
Sanofi and Regeneron’s Dupixent Scores Another Approval for Dermatitis, This Time in Kids
To date, Dupixent is the only biologic approved for this age group.
May 26, 2020
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3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 26, 2020.
May 26, 2020
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4 min read
 · 
BioSpace Editorial Staff
Kynmobi got approved stamp from FDA
FDA
FDA Gives Thumbs-Up to Sunovion’s Under-the-Tongue Parkinson’s Drug Kynmobi
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.
May 22, 2020
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3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: May 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 22, 2020.
May 22, 2020
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4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
May 21, 2020
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4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
May 20, 2020
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6 min read
 · 
BioSpace Editorial Staff
FDA
Lynparza Becomes Second PARP Inhibitor Approved for Prostate Cancer, Just Days Behind the First
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
May 20, 2020
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3 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 19, 2020.
May 19, 2020
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4 min read
 · 
BioSpace Editorial Staff
FDA
FDA Grants Genentech’s Checkpoint Inhibitor Tecentriq Another NSCLC Approval
The approval was based on interim analysis from the company’s Phase III IMpower110 trial.
May 19, 2020
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2 min read
 · 
Mark Terry
FDA
Clovis Oncology’s PARP Inhibitor Rubraca Gets Greenlight from FDA in Prostate Cancer
With the new approval, Rubraca becomes the first PARP inhibitor approved in a prostate cancer setting.
May 18, 2020
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2 min read
 · 
Alex Keown
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