FDA’s National Priority Voucher Program Is Just a Modular PMA Rebrand, With Risks
In June 2025, FDA announced its new Commissioner’s National Priority Voucher (CNPV) program, a headline-grabbing reform that promises to...
C4’s Cemsidomide Data Supports Best-in-Class Myeloma Drug
C4 Therapeutics reported a 50% overall response rate at 100 µg and 40% at 75 µg for cemsidomide plus...
Kensana Health’s $120M Surge Fuels Plant Medicine Future
Kensana Health secured a share subscription facility of up to $120 million with GEM Global Yield, available for 36...
SKYE Presents New Phase 1b Nimacimab Data at EASD Meeting
No serious adverse events, no discontinuations due to adverse events, and no neuropsychiatric safety signals were observed in a...
PDS Biotech Breakthrough Extends Head & Neck Cancer Survival
In a Phase 2 sub-analysis of HPV16-positive first-line recurrent or metastatic head and neck squamous cell carcinoma with low...
NKGen Reveals Hope for Neurodegenerative Disease at China Forum
No new efficacy or safety figures were released, but NKGen Biotech plans to present recent clinical data on its...
Successful Phase 2a Study Results for Lipella’s LP-10
All 27 patients completed treatment with no serious adverse events in Lipella’s Phase 2a study of LP-10 for oral...
Gain Therapeutics Begins Promising Parkinson’s Phase 1b Study
In healthy volunteers, GT-02287 increased glucocerebrosidase (GCase) activity by more than 50% at clinically relevant doses, with plasma and...
Intellia Completes Enrollment for Phase 3 HAE Drug Study
Enrollment in Intellia’s global Phase 3 HAELO trial for lonvoguran ziclomeran (lonvo-z; NTLA-2002) is complete nine months after first...
FDA Fast Track: A Breakthrough for Minovia’s MDS Drug MNV-201
FDA granted Fast Track designation to Minovia’s autologous mitochondrial cell therapy MNV-201 for myelodysplastic syndromes, adding a second expedited...