United States Food and Drug Administration
Kane Biotech Announces Third Quarter 2025 Financial Results
Kane Biotech; third quarter 2025; financial results; revenue; gross profit; net loss; revyve; wound care; FDA 510(k) clearance; U.S. distributor network
RapidAI Deepens Partnership with Amazon AWS to Expand Clinical Imaging AI Deployment
RapidAI; Amazon Web Services; AWS; clinical AI; imaging AI; RSNA 2025; FDA clearance; Rapid Edge Cloud; healthcare AI; neurovascular AI; Lumina 3D
FDA’s Vinay Prasad Links 10 Child Deaths to COVID-19 Vaccines, Calls for Stricter Review Guidelines
FDA; Vinay Prasad; COVID-19 vaccines; child deaths; myocarditis; vaccine safety; vaccine regulation; biologics evaluation; VAERS; stricter vaccine guidelines
Keytruda Breaks New Ground with FDA Approval for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
Keytruda; pembrolizumab; perioperative treatment; head and neck squamous cell carcinoma; HNSCC; FDA approval; KEYNOTE-689 trial; neoadjuvant therapy; adjuvant therapy; PD-L1 expression; event-free survival; clinical trial
Marengo’s invikafusp alfa shows promising monotherapy activity in PD-1 resistant gastrointestinal cancers
Invikafusp alfa; Marengo Therapeutics; PD-1 resistant tumors; Gastrointestinal cancers; Colorectal cancer; TMB-H; MSI-H; Immunotherapy; ESMO 2025; FDA Fast Track designation
FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months
FDA; Ascendis Pharma; TransCon CNP; navepegritide; achondroplasia; dwarfism; PDUFA; post-marketing requirement; delay; approval
Otsuka’s Anti-APRIL Antibody (Voyxact/Sibeprenlimab) Receives FDA Approval for IgA Nephropathy (IgAN)
Otsuka; anti-APRIL antibody; Voyxact; sibeprenlimab; FDA approval; IgA nephropathy; IgAN; proteinuria; monoclonal antibody
Imfinzi Gains FDA Approval for Early Gastric and GEJ Cancers; BiomX Nebulizer Faces FDA Scrutiny
Imfinzi; FDA approval; gastric cancer; gastroesophageal cancer; perioperative; BiomX; nebulizer; clinical hold
FDA OKs Sarepta Study of New Immune Suppression Approach with Elevidys; Gilead Acquires Preclinical TREX1 Program
FDA; Sarepta; Elevidys; immunosuppression; Duchenne muscular dystrophy; Gilead; TREX1; gene therapy; sirolimus; acute liver injury
FDA’s Pazdur Raises Concerns Over Legality of National Priority Voucher Program Amid Internal Disagreement
FDA; Pazdur; Commissioner’s National Priority Voucher; CNPV; legality; internal disagreement; tumor board; Tidmarsh; drug approval process