Amino Acid, Peptide, or Protein
Dynavax Highlights Comparable Efficacy and Improved Tolerability of Z-1018 Shingles Vaccine vs. Shingrix
Dynavax; Z-1018; shingles vaccine; Shingrix; vaccine efficacy; side effects; Phase 1/2 trial; immunogenicity
AbbVie’s Rinvoq Achieves Strong Phase 3 Results in Alopecia Areata, Clearing Key Efficacy Milestone
AbbVie; Rinvoq; Phase 3 trial; alopecia areata; hair regrowth; upadacitinib; SALT score; JAK inhibitor
American Academy of Pediatrics Breaks with RFK Jr., CDC on COVID Vaccines for Kids
American Academy of Pediatrics; AAP; COVID-19 vaccine; children; CDC; Robert F. Kennedy Jr.; pediatric immunizations; public health guidance; vaccine policy
CSL Announces Vaccine Unit Spin-Off and Major Workforce Cuts
CSL; Seqirus; vaccine spin-off; workforce reduction; demerger; strategic restructuring; biotech; cost-cutting
FDA Rejects PTC’s Vatiquinone Application for Friedreich’s Ataxia, Requests Further Studies
FDA rejection; PTC Therapeutics; vatiquinone; Friedreich’s ataxia; complete response letter; drug efficacy; additional clinical studies
FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful
PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure
Battle Intensifies in the Obesity Drug Market as Novo Nordisk and Eli Lilly Vie for Dominance
obesity drugs; GLP-1; Wegovy; Zepbound; Novo Nordisk; Eli Lilly; market competition; direct-to-consumer; pharmacy benefit managers; compounders; clinical trials
Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug
Stealth BioTherapeutics; FDA resubmission; rare disease; Barth syndrome; elamipretide; drug approval; expanded access program
Conflicts of Interest Among Federal Vaccine Advisors at Historic Lows Through 2024
conflicts of interest; vaccine advisory committees; ACIP; VRBPAC; CDC; FDA; transparency; Robert F. Kennedy Jr.; JAMA study
FDA Grants Wegovy 3rd Indication: First GLP-1 Approved for MASH with Moderate-to-Advanced Liver Scarring
Wegovy; FDA approval; MASH; semaglutide; GLP-1 receptor agonist; liver fibrosis; Novo Nordisk; ESSENCE trial; noncirrhotic; accelerated approval