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The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...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

FDA oncology draft guidance aims to reduce animal testing

The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...
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 finalizes two guidances for industry on establishing bioequivalence

The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs. “This draft guidance not only ...
STAT

Blood pressure tech floods the market after FDA relaxes wearables oversight

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...
STAT

5 burning questions on the FDA’s new Covid-19 vaccine framework

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.
Healio

FDA-identified uncertainties about new cancer drugs often omitted in journals, guidelines

Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...
Delco Times

Acetaminophen use down after FDA guidance changes

Along with label changes, the agency urged doctors to “prescribe the lowest possible dose for the least amount of time” ...

Actinogen receives positive EMA scientific advice aligned with prior FDA guidance for its Alzheimer’s disease program

XanaMIA randomized, pivotal trial of oral Xanamem 10 mg fully enrolled and remains on track for topline final results in ...