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Stem cells Food and Drug Administration (FDA)

Knobbe Martens

FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease...

Knobbe Martens on

On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Gene Therapy Approvals Gain Steam in 2023: FDA Approves First Gene Therapies for Sickle Cell Disease

In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more

Foley & Lardner LLP

FDA Approves Two Gene Therapies to Treat Sickle Cell Disease Including a CRISPR-Based Therapy

Foley & Lardner LLP on

Share on Twitter Print Share Back to top On December 8, 2023 the U.S. Food and Drug Administration (FDA) approved Casgevy and Lyfgenia, both cell-based gene therapies for the treatment of sickle cell disease in patients 12...more

Womble Bond Dickinson

Cultured Meat 101: The Science and Premarket Process

Womble Bond Dickinson on

Cultured meat and its introduction into our grocery stores and restaurants is on the horizon. The FDA has established a premarket consultation process which allows companies who would like to market cultured meat in the U.S....more

Hogan Lovells

O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

Hogan Lovells on

Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more

Parker Poe Adams & Bernstein LLP

New COVID-19 Vaccine May Provide Option for Religious Objectors

Last week, the Food and Drug Administration (FDA) authorized a fourth coronavirus vaccination, approving a new shot developed by Novavax. Unlike the Pfizer and Moderna products, this vaccine does not use messenger RNA...more

Morgan Lewis - As Prescribed

FDA Talks Regenerative Medicine Advanced Therapy Designation

At the Food and Drug Law Institute’s 2021 annual conference, Dr. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, commented on progress that has been made using FDA’s Regenerative Medicine...more

Bradley Arant Boult Cummings LLP

The Government’s Watchful Eye on Fraud Stemming from Stem Cell Therapy

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell...more

Wilson Sonsini Goodrich & Rosati

FDA Delays Regulatory Enforcement of Stem Cells, Other Cellular and Tissue Products

In a move welcomed by industry, the Food and Drug Administration (FDA) has granted six additional months of enforcement discretion to manufacturers of certain human cell, tissue, or cellular or tissue-based products (HCT/Ps)....more

Faegre Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

Mintz - Health Care Viewpoints

Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more

McGuireWoods LLP

Lessons From FDA’s Warning Letter to Stem Cell Product Manufacturer

McGuireWoods LLP on

In August, the U.S. Food and Drug Administration (FDA) issued a stern warning letter to a California-based company for manufacturing and distributing unapproved products derived from umbilical cord blood and for failure to...more

BakerHostetler

FDA and Pharmacy Weekly Digest - September 2019 #2

BakerHostetler on

Food/Dietary Supplements - FDA Issues Reminder to Firms Exporting Collagen, Gelatin or Seafood Products – The FDA reminded exporters to the European Union to use the Export Listing Module (ELM) when exporting food...more

Patrick Malone & Associates P.C. | DC Injury...

Consumers blame, shame and prod corporations to win health safeguards

Consumers, regulators, politicians, and journalists need to keep pressing big corporations to better protect the public’s health because such campaigning can work....more

Hogan Lovells

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Hogan Lovells on

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist...more

Hogan Lovells

What comes out, must go back in: Court sides with FDA on "same surgical procedure" and "homologous use" definitions governing...

Hogan Lovells on

FDA authority to crack down on illegally marketed stem cell treatments confirmed - On 3 June a U.S. District Court in Florida issued a decisive blow against US Stem Cell Clinic LLC, granting the U.S. Food and Drug...more

Hogan Lovells

What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing...

Hogan Lovells on

FDA authority to crack down on illegally marketed stem cell treatments confirmed - On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more

Maynard Nexsen

Stem Cell Recall and Legal Risks

Maynard Nexsen on

A recent nationwide recall of a series of non-Food and Drug Administration (FDA)-approved stem cell products that have infected at least 12 patients has raised serious questions concerning legal exposure to providers that use...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Cell and gene therapies

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Holland & Knight LLP

FDA Issues Warning Letter Regarding Unapproved Stem Cell Products

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

FDA Files Complaints in Federal Court Against Two Stem Cell Clinics

FDA historically has limited its enforcement actions against stem cell clinics to warning letters. On May 9, 2018, FDA went a step further and filed two complaints in federal court seeking permanent injunctions that would...more

Hogan Lovells

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

Hogan Lovells on

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more

Hogan Lovells

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

Hogan Lovells on

Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more

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