Browsing Tag
FDA
293 posts
Can seasonal COVID‑19 shots follow the flu vaccine playbook—and will Americans comply in 2025?
Will Americans embrace annual COVID-19 shots like flu vaccines? Explore how LP.8.1, FDA guidance, and public trust shape the 2025 rollout.
BeOne Medicines’ sonrotoclax trial hits primary endpoint in mantle cell lymphoma patients
BeOne Medicines’ sonrotoclax met its primary endpoint in mantle cell lymphoma, with positive Phase 1/2 trial results. Find out what this means for patients.
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.