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U.S. Food & Drug Administration

02-01-2026 - The U.S. Food and Drug Administration today began accepting requests to participate in the FDA PreCheck pilot program. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.

"After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back," said FDA Commissioner Marty Makary, M.D., M.P.H. "The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive." The agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the U.S. market.

The FDA incorporated extensive industry feedback into the program design based on comments made during the "Onshoring Manufacturing of Drugs and Biological Products" public meeting held on Sept. 30, 2025, and public comments received through Federal Register publication. Industry strongly supported early engagement during facility development and streamlined documentation processes. FDA PreCheck consists of two phases. In Phase 1, the Facility Readiness Phase, selected manufacturers will engage with FDA for early technical advice before a facility is operational through pre-operational reviews and utilization of a facility-specific Drug Master File to facilitate efficient evaluation of facility-specific elements prior to, and in support of, the submission of a drug application. In Phase 2, the Application Submission Phase, FDA and applicants build upon Phase 1 and engage through pre-submission meetings and inspections to resolve issues and expedite assessments of manufacturing information in a drug application.

01-29-2026 - Outbreak Investigation of Salmonella: Moringa Leaf Powder - January 29, 2026 - The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Salmonella Typhimurium and Salmonella Newport infections linked to recalled Why Not Natural Pure Organic Moringa Green Superfood capsules and recalled Live it Up-brand Super Greens dietary supplement powder. Since the last update on January 15, 2026, a total of 20 new illnesses have been reported, including a new outbreak strain of Salmonella Newport. As of January 29, 2026, CDC reported a total of 65 people from 28 states that have been infected with one of the outbreak strains of Salmonella. Of the 40 people interviewed, 35 (88%) reported eating a product containing moringa leaf powder, including 31 who reported Live it Up Super Greens supplement powders only, 3 who reported Why Not Natural moringa powder capsules only, and 1 person who reported consuming both products. There have been 14 hospitalizations, and no deaths have been reported.

FDA’s traceback investigation revealed a common manufacturer between Live it Up-brand Super Greens and Why Not Natural Pure Organic Moringa Green Superfood capsules that used moringa leaf powder in both products. Epidemiologic and traceback evidence showed that moringa leaf powder is the source of contamination in this outbreak, and lot # A25G051 of Why Not Natural Pure Organic Moringa Green Superfood capsules with expiration date 07/2028 may be contaminated with the strains of Salmonella making people sick in this outbreak. On January 24, 2026, Art Monkey LLC dba Why Not Natural of Houston, TX stopped the sale of Pure Organic Moringa Green Superfood capsules and initiated a recall of lot # A25G051 on January 28, 2026. FDA is working with the firms to determine a root cause of the contamination and remove affected products from the market. On January 20, 2026, Superfoods, Inc. expanded their recall of Live it Up-brand Super Greens product to include nationwide distribution of recalled product, including Puerto Rico, Guam, and the U.S. Virgin Islands, as well as international distribution to consumers in the United Kingdom.

01-12-2026 - The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.

“With today’s action, children with this devastating, degenerative disease will have an FDA-approved treatment option and the potential to live longer,” said Christine Nguyen, M.D., Deputy Director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “The FDA will continue to work with the rare disease community to advance drug development for patients with Menkes disease and other rare conditions.”

Menkes disease is a neurodegenerative disorder caused by a genetic defect that impairs a child’s ability to absorb copper. The disease is characterized by seizures, failure to gain weight and grow, developmental delays, and intellectual disability. It leads to abnormalities of the vascular system, bladder, bowel, bones, muscles, and nervous system. Children with classical Menkes (90% of those with the disease) begin to develop symptoms in infancy and typically do not live past three years. It affects approximately one in every 100,000-250,000 live births worldwide and is more common in boys.

Zycubo is a copper replacement therapy given by subcutaneous injection. It delivers copper in a form that bypasses the genetic defect in intestinal absorption, allowing the body to better use the mineral.

The FDA evaluated Zycubo in two open-label, single-arm clinical trials in pediatric patients treated for up to three years. Overall survival was assessed by comparing treated patients to untreated patients from contemporaneous external control groups. The analysis included 66 treated patients and 17 untreated patients, most of whom were from the United States.

Children who began treatment within four weeks of birth had a 78% reduction in the risk of death compared with untreated patients. Nearly half of early-treated patients survived beyond six years, and some survived more than 12 years. No patients in the untreated control group survived beyond six years. Children who started treatment later than four weeks after birth also experienced a substantial survival benefit.

The most common side effects reported with Zycubo included infections, respiratory problems, seizures, vomiting, fever, anemia and injection site reactions. Because copper can accumulate in the body, patients receiving Zycubo should be closely monitored for potential toxicity.

“This approval marks an unprecedented advance for children with Menkes disease,” said Tracy Beth Hoeg, M.D., Ph.D., Acting Director of CDER. “The company demonstrated a large improvement in overall survival compared with untreated patients, using an innovative trial design that addressed the challenges of studying an ultra-rare disease.”

This application received Priority Review, Fast Track Designation, Breakthrough Therapy Designation, and Orphan Drug Designation. The FDA approved Zycubo for Sentynl Therapeutics.