Governmental or Regulatory Activity

Junshi Biosciences Announces Phase 3 Win for IL-17A Drug JS005 in Psoriasis, Prepares China NDA Submission

2 days ago talkbio0Tagged Biosciences, China, clinical endpoints, Drug Approval, IL-17A monoclonal antibody, JS005, Junshi, Psoriasis

Junshi Biosciences; JS005; IL-17A monoclonal antibody; psoriasis; phase 3 trial; clinical endpoints; China drug approval

FDA Shifts Approach on GLP-1 Compounding: Announces Consumer Green List Instead of Immediate Crackdown

2 days ago talkbio0Tagged Compound, Consumer Safety, Drug shortages, Glucagon-Like Peptide 1, green list, import alert, Regulation, semaglutide, United States Food and Drug Administration

FDA; GLP-1; compounding; green list; drug shortages; semaglutide; tirzepatide; import alert; consumer safety; regulation

FDA Releases Second Batch of Complete Response Letters, Moves to Real-Time Public Disclosure

6 days ago talkbio0Tagged Complete, CRLs, Drug Approval, real-time publishing, regulatory disclosure, Response Letters, Translucent, United States Food and Drug Administration

FDA; Complete Response Letters; CRLs; real-time publishing; drug approvals; transparency; regulatory disclosure

Paul Offit, RFK Jr. Critic, Removed from Key FDA Vaccine Panel

1 week ago talkbio0Tagged Advisory Committees, CHARGE Syndrome, Paul Offit, Policy, removal technique, RFK Jr., United States Food and Drug Administration, vaccine panel, Vaccines, VRBPAC

Paul Offit; FDA; vaccine panel; RFK Jr.; removal; vaccine policy; VRBPAC; advisory committee; HHS

FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns

2 weeks ago talkbio0Tagged Adverse event, Cessation of life, chikungunya vaccine, Encephalitis, Hospitalization, Ixchiq, license suspension, Safety, United States Food and Drug Administration, Valneva

FDA; Valneva; Ixchiq; chikungunya vaccine; license suspension; safety; serious adverse events; encephalitis; hospitalizations; deaths

Tariffs and MFN Policy Power a Broad, Confusing Pharma War

3 weeks ago talkbio0Tagged Drug Industry, drug manufacturing, Drug Prescriptions, Medicaid, MFN, Nation, onshoring, pharma innovation, Policy, Trump administration

tariffs; Most Favored Nation (MFN) policy; prescription drug pricing; pharmaceutical industry; Trump administration; drug manufacturing; onshoring; Medicaid; pharma innovation

Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug

3 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, access program, Drug Approval, Elamipretide, Infrequent, resubmission, Stealth BioTherapeutics, United States Food and Drug Administration

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

3 weeks ago talkbio0Tagged ACIP, Advisory Committees, Centers for Disease Control and Prevention (U.S.), JAMA study, Robert F. Kennedy Jr., Translucent, United States Food and Drug Administration, Vaccines, VRBPAC

conflicts of interest; vaccine advisory committees; ACIP; VRBPAC; CDC; FDA; transparency; Robert F. Kennedy Jr.; JAMA study

HHS Revives ’90s-Era Task Force to Improve Childhood Vaccine Safety

4 weeks ago talkbio0Tagged Adverse reactions, Advisory Committees, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Childhood, Childhood Vaccines, Jay Bhattacharya, NIH Mouse, Robert F. Kennedy Jr., United States Food and Drug Administration, Vaccine Safety, Vaccines

HHS; childhood vaccines; vaccine safety; task force; Robert F. Kennedy Jr.; Jay Bhattacharya; NIH; FDA; CDC; vaccine oversight; adverse reactions; childhood immunization schedule

US to Stockpile Critical Drug Ingredients Under Latest Trump Executive Order

4 weeks ago talkbio0Tagged ASPR, domestic manufacturing, drug ingredients, essential medicines, executive order, National Security, Pharmaceutical Ingredients Reserve, Pharmaceutical Supply Chain, strategic, Transplant Registry Unified Management Program

Trump; Executive Order; drug ingredients; pharmaceutical supply chain; Strategic Active Pharmaceutical Ingredients Reserve; ASPR; domestic manufacturing; national security; essential medicines