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Editorial
BioSpace elevates journalism as biopharma evolves in the Trump era
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
April 24, 2026
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4 min read
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Jef Akst
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Opinion
Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust
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
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
FEATURED STORIES
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FDA
Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
April 17, 2026
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5 min read
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Heather McKenzie
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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THE LATEST
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
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 18, 2020.
May 18, 2020
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5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 15, 2020.
May 15, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 14, 2020.
May 14, 2020
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3 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 13, 2020.
May 13, 2020
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3 min read
 · 
BioSpace Editorial Staff
FDA approved Ascendis Pharma’s Skytrofa.
FDA
Report: NDA, BLA Approvals by the FDA Fell 16% in 2019
A new report released on Tuesday by GlobalData suggested that there was a 16% decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration last year.
May 12, 2020
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2 min read
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Krystle Vermes
Drug Development
Biopharma Update on the Novel Coronavirus: May 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020.
May 12, 2020
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3 min read
 · 
BioSpace Editorial Staff
FDA
Abbott Earns Emergency Use Authorization for Another COVID-19 Antibody Test
Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them.
May 11, 2020
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2 min read
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Alex Keown
TARPEYO is the first FDA-approved drug for immunog
FDA
AstraZeneca and Merck’s Lynparza Approved For Ovarian Cancer Just a Week After GSK’s Zejula
The Lynparza approval isn’t as broad as the Zejula approval, with Lynparza not approved for use in patients with homologous recombination deficiencies.
May 11, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 11, 2020.
May 11, 2020
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4 min read
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BioSpace Editorial Staff
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