Browsing Tag
FDA
293 posts
OS Therapies eyes global approvals for OST-HER2 after breakthrough osteosarcoma vaccine trial
OS Therapies’ OST-HER2 cancer vaccine shows strong survival gains in Phase IIb osteosarcoma trial—discover what comes next for global approval.
Teva’s new bipolar breakthrough: FDA clears UZEDY as the first monthly long-acting risperidone
Teva’s UZEDY long-acting injectable gains FDA approval for bipolar I maintenance, reshaping psychiatric treatment and investor sentiment.
OS Therapies reports statistically significant 75% two-year survival with OST-HER2, eyes 2026 FDA approval
Find out how OS Therapies’ OST-HER2 achieved 75 % two-year survival in osteosarcoma and could secure FDA approval by 2026.
Quoin Pharmaceuticals raises up to $104.5M in private placement to fuel its rare disease pipeline
Find out how Quoin Pharmaceuticals secured up to $104.5 million in a milestone-linked private placement to advance its rare disease therapy QRX003 and strengthen investor confidence.
Regulatory breakthrough: What the MHRA–FDA tie-up means for medtech approvals
Find out how the MHRA–FDA collaboration is reshaping medical device regulation, AI safety, and faster patient access across the UK and US healthcare systems.
Johnson & Johnson (NYSE: JNJ) gains FDA approval to expand SIMPONI into pediatric ulcerative colitis
FDA approves SIMPONI (golimumab) for children ≥15 kg with ulcerative colitis, expanding Johnson & Johnson’s immunology portfolio. Learn what it means for patients.
FDA greenlights Envoy Medical’s fully implanted cochlear implant trial — could this be the biggest leap in hearing restoration yet?
Find out how Envoy Medical’s FDA-cleared Acclaim cochlear implant trial is redefining the future of fully implanted hearing technology.
Toddlers get a breakthrough eczema treatment as FDA clears Arcutis’ ZORYVE cream 0.05%
Find out how Arcutis’ FDA-approved ZORYVE 0.05% cream is reshaping the pediatric eczema market and investor confidence in 2025.
Valneva slashes 2025 outlook after FDA suspends Ixchiq license, shaking investor confidence
Valneva slashes 2025 outlook after FDA suspends Ixchiq license—discover how the biotech aims to rebuild confidence and cash flow stability.
AbbVie and Calico secure FDA fast track designation for kidney disease therapy ABBV-CLS-628
AbbVie and Calico’s kidney drug ABBV-CLS-628 wins FDA Fast Track status for ADPKD, reshaping biotech strategy and investor sentiment.