Browsing Tag
FDA
341 posts
Coya Therapeutics gets FDA green light for Phase 2 ALS trial with COYA 302
Coya Therapeutics receives FDA clearance to initiate a Phase 2 trial of COYA 302 for ALS. Find out what this means for investors and the ALS drug pipeline.
Innovent Biologics secures FDA greenlight for first global Phase 3 trial of IBI363 in lung cancer
Innovent Biologics wins FDA approval for its first global Phase 3 trial of IBI363 in lung cancer, signaling a major milestone in immuno-oncology.
Can remote scanning platforms solve the U.S. technologist shortage faster than training programs?
Remote imaging platforms like TechLive promise to ease the technologist shortage. But can they scale faster than training programs?
Ategenos unveils SmartPatch to tackle $528bn medication non-adherence crisis
Ategenos debuts SmartPatch, a first-of-its-kind connected patch tackling $528bn medication non-adherence with real-time, IoT-enabled monitoring.
OS Therapies reports strong survival benefit in Phase 2b osteosarcoma trial, eyes FDA accelerated approval
OS Therapies’ OST-HER2 trial shows 66.6% two-year survival in recurrent pulmonary osteosarcoma. Find out what this could mean for FDA approval.
DeepHealth gains FDA clearance for remote imaging platform as RadNet pushes connected ecosystem
DeepHealth wins FDA clearance for TechLive, enabling remote scanning across MRI, CT, and PET/CT. Find out how RadNet is reshaping imaging.
pH-D Feminine Health initiates landmark FDA-cleared Phase 3 trial for boric acid suppositories in yeast infection treatment
pH-D Feminine Health begins first FDA-cleared Phase 3 trial for boric acid suppositories, aiming for NDA approval and a breakthrough in recurrent yeast infection treatment.
FDA crackdown on compounded HCG prompts urgent compliance warning from NuCare Pharmaceuticals
NuCare Pharmaceuticals warns U.S. clinics of legal and safety risks tied to compounded HCG after FDA ban; urges shift to approved supply sources.
MiRus earns NTAP approval for EUROPA cervical fusion system, expanding clinical and reimbursement footprint
MiRus receives CMS NTAP approval for its EUROPA Posterior Cervical Fusion System, boosting adoption and access for Medicare patients with spine disorders.
How the White House’s AI push is reshaping healthcare stocks like Avant Technologies and GE HealthCare
Avant Technologies and Ainnova Tech take Vision AI closer to FDA approval as White House backs AI in healthcare with regulatory sandboxes and pilot incentives.