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Dr. Sarah Mitchell

Dr. Sarah Mitchell PharmD, RPh

Senior FDA Regulatory Correspondent

20 articles 🇺🇸 Americas

Dr. Mitchell has over 15 years of experience covering FDA drug approvals and regulatory policy.

FDA regulatorydrug approvalsoncology

Articles by Dr. Sarah Mitchell

CRISPR Therapeutics' CASGEVY Reaches 60,000+ Eligible Patients Across 10 Countries Following Global Approvals
NewsHematology/Blood DisordersMay 4, 2026

CRISPR Therapeutics' CASGEVY Reaches 60,000+ Eligible Patients Across 10 Countries Following Global Approvals

CRISPR Therapeutics reports CASGEVY now approved in 10 countries for severe sickle cell disease and beta thalassemia, reaching over 60,000 eligible patients worldwide.

Dr. Sarah Mitchell
mBIOTA Elemental Diet Shows Promise for IBS Treatment in New Clinical Trial Data Presented at DDW 2026
NewsMay 4, 2026

mBIOTA Elemental Diet Shows Promise for IBS Treatment in New Clinical Trial Data Presented at DDW 2026

New clinical trial data validates mBIOTA Elemental as effective IBS therapeutic, showing symptom improvement across all three IBS subtypes at DDW 2026.

Dr. Sarah Mitchell
Novartis Receives Health Canada Approval for Fabhalta Oral Treatment for C3G Patients
NewsMay 4, 2026

Novartis Receives Health Canada Approval for Fabhalta Oral Treatment for C3G Patients

Health Canada approves Novartis' Fabhalta (iptacopan) oral treatment for adults with complement 3 glomerulopathy, offering new hope for rare kidney disease patients.

Dr. Sarah Mitchell
ASCO 2026: Cellectar's Waldenström Macroglobulinemia Data
NewsgeneralMay 4, 2026

ASCO 2026: Cellectar's Waldenström Macroglobulinemia Data

Cellectar Biosciences will present CLOVER WaM (iopofosine I 131) data at ASCO 2026, focusing on efficacy subset data in relapsed/refractory Waldenström macroglobulinemia.

Dr. Sarah Mitchell
Cytokinetics to Report Aficamten Phase 3 Trial Results for Non-Obstructive Hypertrophic Cardiomyopathy May 5, 2026
NewsMay 4, 2026

Cytokinetics to Report Aficamten Phase 3 Trial Results for Non-Obstructive Hypertrophic Cardiomyopathy May 5, 2026

Cytokinetics announces topline results from pivotal ACACIA-HCM Phase 3 trial of aficamten for non-obstructive hypertrophic cardiomyopathy on May 5, 2026.

Dr. Sarah Mitchell
Excipient World Conference: Key Highlights and Industry Trends
NewsgeneralMay 4, 2026

Excipient World Conference: Key Highlights and Industry Trends

The Excipient World Conference 2026 highlighted major advances in pharma excipients, including innovations in drug delivery, regulatory compliance strategies, and sustainable formulation technologies shaping the future of pharmaceutical development.

Dr. Sarah Mitchell
APHL 2026 Annual Meeting: Day 1 Highlights
NewsgeneralMay 4, 2026

APHL 2026 Annual Meeting: Day 1 Highlights

Day 1 of the APHL 2026 Annual Meeting featured discussions on innovative diagnostic approaches and collaborative strategies in public health laboratory science.

Dr. Sarah Mitchell
APHL 2026: Day 1 Highlights and Key Takeaways
NewsgeneralMay 4, 2026

APHL 2026: Day 1 Highlights and Key Takeaways

Day 1 of APHL 2026 focused on innovations in public health laboratory practices and emerging technologies. The opening keynote addressed the importance of data-driven decision-making in public health.

Dr. Sarah Mitchell
THMA Pharmacy Growth Priorities 2026: Key Insights for CPOs
NewscardiologyMay 4, 2026

THMA Pharmacy Growth Priorities 2026: Key Insights for CPOs

The Health Management Academy has released 2026 strategic priorities for Chief Pharmacy Officers, emphasizing workforce resilience, AI governance, and revenue cycle optimization amid policy pressures and evolving market demands.

Dr. Sarah Mitchell
CPhI Americas 2026: Pharma Manufacturing Trends in Philadelphia
NewsmanufacturingMay 4, 2026

CPhI Americas 2026: Pharma Manufacturing Trends in Philadelphia

CPhI Americas 2026 returns to Philadelphia, focusing on pharmaceutical manufacturing trends, contract manufacturing, AI integration, and regulatory shifts. The event is a key meeting point for industry professionals to discuss the evolving landscape.

Dr. Sarah Mitchell
IPEC Americas Annual Meeting: Key Takeaways for Pharma
NewsgeneralMay 4, 2026

IPEC Americas Annual Meeting: Key Takeaways for Pharma

The IPEC Annual Meeting 2026 pharmaceutical event status remains unconfirmed by official sources. Pharma professionals should monitor the International Pharmaceutical Excipients Council for updates on this critical industry conference addressing excipient innovation, regulatory compliance, and supply chain resilience.

Dr. Sarah Mitchell
Excipient World Conference: Day 1 Highlights
NewsgeneralMay 4, 2026

Excipient World Conference: Day 1 Highlights

The Excipient World Conference 2026 opened with industry-wide focus on pharmaceutical excipient innovations, regulatory compliance, and supply chain collaboration. Day 1 featured presentations on advanced drug delivery systems, stability enhancement technologies, and evolving global standards for excipient qualification.

Dr. Sarah Mitchell
APHL 2026 Annual Meeting: Key Takeaways from Day 1
NewsgeneralMay 4, 2026

APHL 2026 Annual Meeting: Key Takeaways from Day 1

Day 1 of the APHL 2026 Annual Meeting highlighted advancements in public health laboratory science and the importance of collaboration, covering topics from infectious disease control to laboratory technology innovations. Networking events fostered discussions and partnerships to tackle public health challenges.

Dr. Sarah Mitchell
XtalPi-Enabled PEP08 PRMT5 Inhibitor Begins Phase I Cancer Trial Enrollment
NewsMay 4, 2026

XtalPi-Enabled PEP08 PRMT5 Inhibitor Begins Phase I Cancer Trial Enrollment

XtalPi and PharmaEngine's AI-discovered PRMT5 inhibitor PEP08 starts Phase I solid tumor trial enrollment, marking a key milestone in synthetic lethality cancer treatment.

Dr. Sarah Mitchell
Everads Therapy Publishes First-in-Human Clinical Data for Suprachoroidal Injector in Ophthalmology Science
NewsMay 4, 2026

Everads Therapy Publishes First-in-Human Clinical Data for Suprachoroidal Injector in Ophthalmology Science

Everads Therapy reports favorable safety and tolerability data for its novel suprachoroidal drug delivery device in first-in-human trial published in peer-reviewed journal.

Dr. Sarah Mitchell
IPEC Annual Meeting 2026: No Pharma News Today
NewsgeneralMay 4, 2026

IPEC Annual Meeting 2026: No Pharma News Today

No official confirmation or breaking pharmaceutical news from the IPEC Annual Meeting 2026 is currently available in public sources. Pharmaceutical professionals should verify event status directly with the International Pharmaceutical Excipients Council.

Dr. Sarah Mitchell
Excipient World Conference 2026: No Pharma Breaking News
NewsgeneralMay 4, 2026

Excipient World Conference 2026: No Pharma Breaking News

The Excipient World Conference 2026 has not generated breaking pharmaceutical news as of May 4, 2026. However, emerging market trends in lipid-based vitamin C, natural oil excipients, and biodegradable packaging solutions provide strategic insights for pharma excipient professionals.

Dr. Sarah Mitchell
APHL 2026 Annual Meeting Opens: Public Health Lab Focus
NewsgeneralMay 4, 2026

APHL 2026 Annual Meeting Opens: Public Health Lab Focus

The APHL 2026 Annual Meeting commenced today in Baltimore, MD, bringing together public health laboratory leaders, scientists, and partners to discuss critical issues and advancements in the field. The conference, running from May 4–7, will address key trends in laboratory science and public health.

Dr. Sarah Mitchell
MHRA Post-Brexit Drug Approval: What You Need to Know
AnalysisMay 2, 2026

MHRA Post-Brexit Drug Approval: What You Need to Know

Learn about the MHRA's new drug approval process post-Brexit and its impact on the availability of essential medications like Ozempic for diabetes.

Dr. Sarah Mitchell
MHRA Divergence from EMA: What You Need to Know for EU Market Access
AnalysisMay 2, 2026

MHRA Divergence from EMA: What You Need to Know for EU Market Access

This article explores the key differences between MHRA and EMA regulations, focusing on how they affect market access for drugs like XYZ in the EU.

Dr. Sarah Mitchell