Miamisburg-based Riverain Technologies receives FDA clearance for AI-powered imaging software
A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...
Business Wire1d
LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has ac ...
STAT1d
The biggest biotech news stories from the weekend
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. The ...
The American Journal of Managed Care4d
Evolent’s Wonsettler Sees Outcomes-Based Reimbursement as “A Healthy Tool”
Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...
BioSpace4d
FDA Approval of Vertex’s Non-Opioid Journavx Signals New Era in Pain Treatment
If the attention generated by BioSpace’s coverage of this landmark approval is any indication, Americans are hungry for ...
Targeted Oncology5d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
FDA approves Symbravo for acute treatment of migraine in adults
The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...
Pharmaceutical Technology6d
Valneva’s chikungunya vaccine wins UK approval
Valneva’s chikungunya vaccine Ixchiq has been greenlit by the UK’s MHRA, allowing the single-dose vaccine to be made ...
Valneva Receives Marketing Authorization in the UK for the World’s First Chikungunya Vaccine, IXCHIQ®
The UK approval marks the fourth regulatory approval Valneva has received for its single-shot chikungunya vaccine. The vaccine is currently approved in the United States (U.S.) 2, Europe 3 and Canada ...
The Scientist7d
“Man on Fire” Syndrome, Ion Channels, and the Quest for Safer Pain Treatments
In 2004, a research group at Peking University First Hospital discovered a mutation in the gene coding for a sodium-channel ...
GEN8d
Optimizing AAV Gene Delivery: Hitting the Target Safely and Effectively
Researchers are enhancing the best features of AAV capsids and overcoming their limitations to accelerate gene-based therapies.
BioWorld11d
Vertex wins FDA nod for Journavx, new mechanism for acute pain
An effort two decades in the making, Vertex Pharmaceuticals Inc.’s suzetrigine gained U.S. FDA approval as the first drug targeting the NaV1.8 pain signal. Branded Journavx, the oral small molecule is ...