Axios on MSN

FDA issues industry-friendly gene therapy guidance

The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...
PharmExec

New FDA Draft Guidance Targets Gene Therapy Submission Burden by Allowing Use of Existing CMC and Scientific Knowledge

FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...

US FDA proposes using existing science to speed up gene therapy development

June 2 (Reuters) - The U.S. Food and Drug Administration on Tuesday proposed allowing makers of cell and gene therapies ...
PharmTech

FDA Guidance for Accelerating Gene Therapies for Rare Diseases

Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...
Regulatory Affairs Professionals Society

FDA, industry discuss need for flexibility in early phase clinical development of cell therapy products

More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) ...
pharmaphorum

FDA prior knowledge guide seeks to speed cell, gene therapy

In the latest part of its plan to cut barriers to cell and gene therapy (CGT) development, the FDA has published draft ...
RAPS

Stakeholders seek clarity on FDA cell and gene therapy draft guidance

Industry, medical societies and other stakeholders have weighed in on draft guidance from the US Food and Drug Administration (FDA) detailing how sponsors that want to study multiple versions of cell ...
MarketWatch

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

The MarketWatch News Department was not involved in the creation of this content. White Oak, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is sharing ...
Morning Overview on MSN

Gladstone and UCSF scientists screened pre-existing drug databases to find Alzheimer’s reversers, skipping the years it takes to invent new ones

Scientists at Gladstone Institutes and UCSF have turned to computational shortcuts to find Alzheimer’s treatments among drugs ...