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FDA
Makary’s ‘Conditional Approval’ Pathway for Rare Diseases Poses More Questions Than Answers
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.
May 19, 2025
·
10 min read
·
Heather McKenzie
Clinical Research
FDA, NIH Accelerate Shift Away From Animal Research as Experts Warn of Limitations
The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain.
May 19, 2025
·
6 min read
·
Natalia Mesa
Opinion
Slashing FDA Regulations Is Unlikely to Save Money for Industry
While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple reasons it’s unlikely to work out that way.
May 19, 2025
·
4 min read
·
Jessica Taylor
Press Releases
Aligos Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) to a newly hired employee
May 16, 2025
·
2 min read
Press Releases
BlueSphere Bio Appoints Alan Korman, Ph.D. as Chief Scientific Officer
May 16, 2025
·
4 min read
Press Releases
Waters Corporation to Present at the Jefferies Global Healthcare Conference
May 16, 2025
·
1 min read
Press Releases
Coya Therapeutics to Participate at the H.C. Wainwright 3rd Annual BioConnect Investor Conference
May 16, 2025
·
6 min read
Press Releases
Acuitas Therapeutics Showcases Collaboration with Children’s Hospital of Philadelphia for Personalized CRISPR Therapy and New LNP Research at ASGCT 2025
May 16, 2025
·
6 min read
Press Releases
JCR Pharmaceuticals Presents Preclinical Gene Therapy Data that Demonstrate Promising CNS Uptake at American Society of Gene and Cell Therapy 28th Annual Meeting
May 16, 2025
·
6 min read
Press Releases
BiaCure Therapies Awarded SBIR Phase II Grant to Advance Development of High-Frequency Energy Technology for the Treatment of Onychomycosis
May 16, 2025
·
2 min read
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