Posted inNews and Updates
New FDA Guidance: Shaping the Future of Psychedelic Therapy
Discover how the FDA’s new regulatory framework for psychedelic clinical trials is setting rigorous safety and efficacy standards for psychiatric care.
Posted inNews and Updates
FDA Approves First Therapy for SMA-Related Muscle Loss
The FDA has approved apitegromab, the first myostatin inhibitor for SMA, offering a new way to treat muscle atrophy alongside standard genetic therapies.
Posted inNews and Updates
AstraZeneca’s Etcamah Phase III Breast Cancer Trial Fails
AstraZeneca stops Phase III EMBER-3 trial for Etcamah after the drug fails to improve progression-free survival in first-line breast cancer patients.
Posted inNews and Updates
Breakthrough Laser Therapy Targets Inoperable Pancreatic Cancer
A new clinical trial uses targeted laser light to destroy inoperable pancreatic tumors. Learn how this breakthrough photodynamic therapy works.
Posted inNews and Updates
Dynamic Portfolio Growth: Two Lead Drugs Near Launch
Biopharma leader DYN is accelerating toward a dual-drug commercial launch backed by strong clinical data, expanded research, and a solid financial runway.
Posted inNews and Updates
FDA Seeks Public Input on Regulating AI Medical Devices
The FDA is seeking public feedback on regulating GenAI in medical devices. Learn about the new efforts to manage safety, bias, and innovation in AI healthcare.
Posted inNews and Updates
EGTX Rare Disease Strategy: Clinical Gains Fuel Growth
EGTX reports strong clinical data and eyes a U.S. launch. Discover how pipeline expansion is driving growth in the rare disease therapy market.
Posted inNews and Updates
New Travel Insurance Covers Rare Disease Clinical Trials
Markel launches a specialized travel insurance policy to support rare disease patients participating in global clinical trials, ensuring safer access.
Posted inNews and Updates
Clearmind Medicine Begins First Human Trial for CMND-100
Clearmind Medicine has officially enrolled its first patients in a clinical trial for CMND-100, a potential new treatment for Alcohol Use Disorder.
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FDA Review Update: Spectral Medical’s PMX Therapy Status
Spectral Medical meets with the FDA to discuss the PMX device PMA application for treating septic shock. Get the latest update on this critical review.