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Regulatory
‘All Wrapper, No Gift’: FDA Releases New Rare Disease Approval Framework
While the new framework signals continued flexibility at the FDA regarding rare disease approvals, some analysts and advocates question what tangible impacts the new guidelines will have.
September 4, 2025
·
2 min read
·
Tristan Manalac
Vaccines
Prasad Demands YouTube Remove Videos Where He Criticized COVID-19 Vaccines
YouTube has shut down a channel containing hundreds of videos of comments made by doctors and other influencers—including CBER Director Vinay Prasad, Health Secretary Robert F. Kennedy Jr. and NIH Director Jay Bhattacharya—during the pandemic. This comes as Prasad reveals further details about last week’s updated COVID-19 approvals.
September 4, 2025
·
2 min read
·
Tristan Manalac
Press Releases
KalVista Pharmaceuticals to Provide Operational Update and Fiscal Quarter Financial Results on September 11, 2025
September 4, 2025
·
1 min read
Press Releases
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - September 4, 2025
September 4, 2025
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1 min read
Press Releases
Orbital Therapeutics Appoints Accomplished Drug Developer Adam Raff, M.D., Ph.D., as Senior Vice President, Clinical Development
September 4, 2025
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3 min read
Press Releases
Soligenix Announces Publication Describing Long-Term High Temperature Stability of Protein Subunit Vaccines for Ebola and Related Viruses
September 4, 2025
·
11 min read
Press Releases
Zevra Therapeutics Presents Positive New Data Supporting Foundational Role of MIPLYFFA® (arimoclomol) for the Treatment of Niemann-Pick Disease Type C at the International Congress of Inborn Errors of Metabolism (ICIEM)
September 4, 2025
·
8 min read
RNA editing
Wave Crashes Despite Successful RNA Editing in AATD Study
Wave’s RNA editor resulted in protein levels that were “exceedingly close” to what investors were expecting, but nevertheless fell short of that bar, according to analysts at Truist Securities.
September 4, 2025
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2 min read
·
Tristan Manalac
Press Releases
Nuvectis Pharma to Participate at the H.C. Wainwright 27th Annual Global Investment Conference
September 4, 2025
·
1 min read
Press Releases
CorVista Health Announces Publication of Real-World Case Series in the Journal of the American College of Cardiology Exploring its Non-Invasive Test for Earlier Diagnosis of Pulmonary Hypertension
September 4, 2025
·
5 min read
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