United States Food and Drug Administration
FDA Issues Draft Guidance on MRD and CR Endpoints for Accelerated Multiple Myeloma Drug Approvals
FDA guidance; multiple myeloma; MRD; complete response; accelerated approval
IntraBio’s Levacetylleucine Succeeds in Phase 3 Trial for Ataxia-Telangiectasia, Plans FDA and EMA Approval
IntraBio; levacetylleucine; Ataxia-Telangiectasia; Phase 3; FDA approval; EMA; rare disease
Makary Proposes Higher FDA User Fees for Non-US Phase I Trials to Counter China Biotech
Makary; FDA; user fees; China; biotech; Phase I trials; America First
Teva Launches First Generic GLP-1 for Weight Loss Amid Ongoing Market Developments
generic GLP-1; Teva; liraglutide; Saxenda; FDA approval; weight loss drugs
FDA Delays Reviews for Eli Lilly, Sanofi, and Others in New Priority Voucher Program Due to Safety and Efficacy Concerns
FDA delays; Eli Lilly; Sanofi; voucher program; orforglipron; Tzield; safety concerns; efficacy issues
JPM26 Day 3: Sanofi CEO on RSV Scrutiny and Regeneron Dupixent Defense
JPM26; Sanofi; RSV; Beyfortus; Paul Hudson; FDA; vaccines; Dupixent; Regeneron
FDA Requests Eli Lilly and Novo Nordisk to Remove Suicide Warnings from GLP-1 Drug Labels
FDA; GLP-1; suicide warnings; Eli Lilly; Novo Nordisk; Wegovy; Zepbound; Saxenda
FDA Requests Flu Vaccine Label Updates for Febrile Seizure Risk in Young Children
FDA; flu vaccine; febrile seizures; label update; children; influenza vaccine
Sentynl Therapeutics Receives FDA Approval for ZYCUBO, First US Treatment for Rare Menkes Disease
Sentynl Therapeutics; ZYCUBO; FDA approval; Menkes disease; copper histidinate; Zydus Lifesciences
FDA Lifts Partial Hold on Merck and Daiichi Sankyo’s B7-H3 ADC Trial for Lung Cancer[6]
FDA; partial hold lifted; Merck; Daiichi Sankyo; ifinatamab deruxtecan; I-DXd; B7-H3 ADC; small cell lung cancer; IDeate-Lung02