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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
70 Results
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FDA
FDA’s AI Rollout Raises Questions Around Readiness, Legality
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside experts.
June 30, 2025
·
6 min read
·
Natalia Mesa
Rare diseases
Ultrarare Therapies Could Be Reality with Advances in Tech, Delivery and Regulation
Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible.
June 30, 2025
·
6 min read
·
Dan Samorodnitsky
Approvals
Moderna, Merck, UroGen, Score RSV and Cancer Nods in June
The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month.
June 30, 2025
·
9 min read
·
Tristan Manalac
Press Releases
ProBio Opens Flagship U.S. Plasmid & Viral Vector Manufacturing Facility in Hopewell, New Jersey to Advance Cell and Gene Therapy
June 30, 2025
·
4 min read
Press Releases
Avantor® to Host Second Quarter 2025 Earnings Call on Friday, August 1, 2025
June 30, 2025
·
1 min read
Press Releases
CorMedix Inc. Announces Pricing of Public Offering of Common Stock
June 30, 2025
·
4 min read
Press Releases
New Data for Nusinersen Underscore Biogen’s Commitment to Advancing Clinical Research to Improve Outcomes in SMA
June 30, 2025
·
9 min read
Press Releases
Stowers Institute Investigator Named 2025 Freeman Hrabowski Scholar by HHMI
June 30, 2025
·
3 min read
Press Releases
INmune Bio, Inc. Announces Approximately $19 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
June 30, 2025
·
4 min read
Press Releases
Pliant Therapeutics Provides Update on BEACON-IPF
June 30, 2025
·
6 min read
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