United States Food and Drug Administration
Novo Nordisk Wins FDA Approval for First Oral GLP-1 Wegovy Pill in Obesity Treatment
Novo Nordisk; Wegovy pill; FDA approval; oral semaglutide; obesity treatment; GLP-1
Gilead’s $35M Herpes Deal with Assembly Biosciences and Recent FDA Approvals
Gilead; Assembly Biosciences; herpes; HSV; ABI-1179; ABI-5366; FDA; Boehringer; Roche
FDA Approves Novo Nordisk’s Wegovy Pill as First Oral GLP-1 for Weight Management
Novo Nordisk; Wegovy pill; FDA approval; obesity treatment; oral semaglutide
Spotlight On: Five Key FDA Approvals of 2025
FDA approvals; 2025; orphan drugs; novel therapies; rare diseases
FDA Approves Cytokinetics’ Myqorzo for Obstructive Hypertrophic Cardiomyopathy, Positioning It Against BMS’s Camzyos
FDA approval; Cytokinetics; Myqorzo; aficamten; obstructive hypertrophic cardiomyopathy; Bristol Myers Squibb; Camzyos
FDA places partial clinical hold on Merck and Daiichi Sankyo’s I-DXd lung cancer trial after interstitial lung disease deaths
FDA partial clinical hold; ifinatamab deruxtecan; I-DXd; IDeate-Lung02; Merck; Daiichi Sankyo; small cell lung cancer; interstitial lung disease; grade 5 ILD; antibody-drug conjugate; clinical trial deaths
Recent Biotech News: Altimmune’s Pemvidutide Advances in MASH, Emerging China Obesity Players, and Ipsen Phase 2 Setback
Altimmune; pemvidutide; MASH; Phase 2b; IMPACT trial; FDA; China obesity; Ipsen; Phase 2 fail
Lilly seeks rapid FDA approval for oral GLP-1 orforglipron after positive obesity “switching” study
Eli Lilly; orforglipron; oral GLP-1; FDA approval; national priority review voucher; ATTAIN-MAINTAIN trial; obesity treatment; weight maintenance; Zepbound; Wegovy; injectable incretins; Phase 3 trial
Exclusive: Compounding giant Empower Pharmacy cuts hundreds of staff, stops New Jersey operations
Empower Pharmacy; compounding pharmacy; layoffs; job cuts; New Jersey operations; East Windsor facility; manufacturing shutdown; outsourcing facility; FDA inspection; Form 483; compounded GLP-1 drugs; workforce reduction
FDA Commissioner Makary Addresses COVID-19 Vaccine Safety Concerns Amid Internal Debates and Investigations
Marty Makary; FDA; COVID-19 vaccine; myocarditis; vaccine deaths; safety warnings; RFK Jr.; mRNA vaccines