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Complete response letters
Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbump
An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
July 23, 2026
·
3 min read
·
Tristan Manalac
Press Releases
L7 Informatics Advocates for Neuro-Symbolic AI in Regulated Life Sciences
L7 Informatics’ position is that generative AI has been deployed in regulated science with only half the architecture it needs, and that the missing half is an active knowledge graph generated at the point of execution.
July 23, 2026
·
1 min read
Layoff Tracker
CLINUVEL will cut up to 20% of staff, relocate HQ to New York
Follow along as
BioSpace
tracks job cuts and restructuring initiatives.
July 23, 2026
·
69 min read
·
BioSpace Editorial Staff
Press Releases
iOrganBio Expands Scientific Advisory Board with Appointment of Lee L. Rubin, Ph.D
July 23, 2026
·
2 min read
Manufacturing
BeOne commits $300M to US manufacturing expansion, creating 120 new jobs
The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
July 23, 2026
·
1 min read
·
Gabrielle Masson
Press Releases
Model Medicines to Present New Data on MDL-001 at ASV 2026: Broad-Spectrum Antiviral Activity Across Six Viral Families
Oral presentation unifies the respiratory and hepatic programs. The first-in-class, direct-acting, broad-spectrum, Thumb-1 polymerase inhibitor demonstrates single-agent activity against influenza, RSV, SARS-CoV-2, HCV, HBV, and HDV, including activity against oseltamivir-resistant influenza and oral in vivo proof-of-concept.
July 23, 2026
·
1 min read
Press Releases
Bio-Rad to Report Second-Quarter 2026 Financial Results on Tuesday, August 4, 2026
July 23, 2026
·
1 min read
Press Releases
TECVAYLI® + TALVEY® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma
July 23, 2026
·
32 min read
Press Releases
Beckman Coulter Diagnostics Launches Fully Automated Urinalysis System to Meet Rising Testing Volumes
July 23, 2026
·
6 min read
Press Releases
Caristo Diagnostics Expands Executive Team, Naming David Vort Chief Commercial Officer and Chris Louk Chief Financial Officer
July 23, 2026
·
2 min read
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