Regulatory news – Scendea

Regulatory News & Intelligence

Stay informed with the latest regulatory developments, guideline updates, and industry intelligence to keep your drug development programs on track.

Regulatory Alerts

URGENT: Revised CMC Requirements for Biologics

FDA

New chemistry, manufacturing, and controls requirements effective September 1, 2025.

Updated Safety Reporting Guidelines

EMA

Enhanced pharmacovigilance requirements for advanced therapy medicinal products.

Featured

FDA Approvals

July 25, 2025

4 min read

FDA Advisory Committee Recommends Approval for Novel Gene Therapy

The Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3 in favor of recommending approval for a groundbreaking gene therapy targeting inherited retinal dystrophy, marking a significant milestone in ophthalmology.

Updated Daily

Latest News

Stay Ahead of Regulatory Changes

Subscribe to our regulatory intelligence newsletter and receive curated updates, analysis, and insights delivered directly to your inbox.

FDA Advisory Committee Recommends Approval for Novel Gene Therapy

The Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3 in favor of recommending approval for a groundbreaking gene therapy targeting inherited retinal dystrophy, marking a significant milestone in ophthalmology.

Gene Therapy

FDA

Advisory Committee

Ophthalmology

EMA Guidelines

EMA Publishes Updated Guidelines on Advanced Therapy Medicinal Products

New guidance addresses manufacturing, quality controls, and clinical development considerations for cell and gene therapies entering European markets.

ATMPs

EMA

Manufacturing

Quality

Guidelines

MHRA News

MHRA Announces Fast Track Designation for Alzheimer's Treatment

British regulatory authority grants breakthrough therapy designation to innovative monoclonal antibody targeting amyloid plaques in Alzheimer's disease.

Alzheimer's

MHRA

Fast Track

Biologics

Neuroscience

ICH Guidelines

New ICH E9(R1) Guidance on Statistical Analysis Plans Released

International Council for Harmonisation publishes comprehensive guidance on statistical methodologies for clinical trials in pharmaceutical development.

ICH

Statistics

Clinical Trials

E9(R1)

Estimands

FDA Approvals

FDA Approves First CRISPR-Based Treatment for Sickle Cell Disease

Groundbreaking gene editing therapy receives full approval, offering new hope for patients with sickle cell disease and beta-thalassemia.

CRISPR

Gene Therapy

FDA Approval

Sickle Cell

Beta-Thalassemia

Upcoming Events

Workshop

FDA-Industry Workshop on Cell and Gene Therapy Manufacturing

Advisory Meeting

EMA Scientific Advisory Group on Advanced Therapies Meeting

Webinar

MHRA Webinar: Post-Brexit Regulatory Landscape

Stay Ahead of Regulatory Changes

Subscribe to our regulatory intelligence newsletter and receive curated updates, analysis, and insights delivered directly to your inbox.

Join 5,000+ regulatory professionals who trust our insights

Advance Regulatory

Regulatory News & Intelligence

Stay informed with the latest regulatory developments, guideline updates, and industry intelligence to keep your drug development programs on track.

URGENT: Revised CMC Requirements for Biologics

New chemistry, manufacturing, and controls requirements effective September 1, 2025.

Updated Safety Reporting Guidelines

Enhanced pharmacovigilance requirements for advanced therapy medicinal products.

Featured

FDA Approvals

July 25, 2025

4 min read

FDA Advisory Committee Recommends Approval for Novel Gene Therapy

The Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3 in favor of recommending approval for a groundbreaking gene therapy targeting inherited retinal dystrophy, marking a significant milestone in ophthalmology.

Latest News

Stay Ahead of Regulatory Changes

Categories

FDA Advisory Committee Recommends Approval for Novel Gene Therapy

EMA Publishes Updated Guidelines on Advanced Therapy Medicinal Products

MHRA Announces Fast Track Designation for Alzheimer's Treatment

New ICH E9(R1) Guidance on Statistical Analysis Plans Released

FDA Approves First CRISPR-Based Treatment for Sickle Cell Disease

Upcoming Events

FDA-Industry Workshop on Cell and Gene Therapy Manufacturing

EMA Scientific Advisory Group on Advanced Therapies Meeting

MHRA Webinar: Post-Brexit Regulatory Landscape

Stay Ahead of Regulatory Changes

Advance Regulatory

Contact Details

Quick Links

Stay Updated

Member Of