FDA
Coverage of FDA in the Nexus archive.
- First-in-Class Drug Approved for IgA Nephropathy
The FDA granted accelerated approval to atacicept (Trutakna) for reducing proteinuria in adults with primary IgA nephropathy at risk of disease progression. Approval was supported by data from the ORIGIN 3 trial for the once-weekly self-administered drug.
- STAT+: FDA approves Vera Therapeutics kidney disease treatment
The FDA approved Trutakna, a new treatment for IgA nephropathy, a chronic autoimmune kidney disease, developed by Vera Therapeutics. Vera CEO Marshall Fordyce expressed excitement about bringing the drug to patients.
- STAT+: Pharmalittle: We’re reading about a $10 billion Vertex deal, the pace of FDA drug approvals, and more
Vertex Pharmaceuticals acquired Crinetics Pharmaceuticals for $10 billion, gaining access to Palsonify, a drug for acromegaly, and other drug candidates. The deal marks Vertex's largest acquisition as it expands beyond its cystic fibrosis portfolio.
- STAT+: Pharmalittle: We’re reading about a Novartis acquisition, Republicans backing clinical trial diversity, and more
Novartis acquired Myricx Bio for $1.1 billion to advance its antibody-drug conjugate (ADC) pipeline with a novel NMTi payload. Congressional Republicans passed a bill funding the FDA, including a report urging the agency to implement requirements for diversifying clinical trials.
- Shampoo sold nationwide recalled after bacteria detected. Here are the impacted products
A voluntary recall has been issued for Oribe Serene Scalp Densifying Shampoo due to the detection of Pluralibacter gergoviae bacteria, which can cause infections. Kao USA advises stopping use of affected lots manufactured between Feb. 21, 2026, and Feb. 26, 2026.
- Pedigree dog food recalled for possible metal and plastic contamination
Some canned Pedigree High Protein Chopped Chicken and Duck Flavor dog food is being recalled due to possible metal and plastic contamination. The FDA states the product was fraudulently diverted in the U.S., but no pet illnesses have been reported. Affected cans have lot codes 613C3KKCFC and 613C1KKCFC.
- Pedigree dog food recalled for possible metal and plastic contamination
Some canned Pedigree High Protein Chopped Chicken and Duck Flavor dog food is being recalled due to possible metal and plastic contamination. The FDA states the product was fraudulently diverted in the U.S., but no illnesses have been reported. Consumers are advised not to feed the affected batches to pets and to contact Pedigree for a replacement.
- Pedigree dog food recalled for possible metal and plastic contamination
Some canned Pedigree dog food is being voluntarily recalled due to potential metal and plastic contamination. The affected product is High Protein Chopped Chicken and Duck Flavor with specific lot codes, as reported by the FDA. No illnesses have been reported, and consumers are advised not to feed the recalled product to pets.
- The FDA Ruled That ZYN Pouches Are Safer Than Cigarettes. That Doesn’t Mean They’re Safe
The FDA ruled that ZYN nicotine pouches can be advertised as a less-harmful option for adult smokers compared to cigarettes. However, the article emphasizes that quitting all tobacco and nicotine products remains the best course of action.
- FDA authorizes 20 ZYN nicotine pouches to be marketed with modified risk claim
The FDA authorized 20 ZYN nicotine pouches to carry a modified risk claim. This allows the product to be marketed with a label indicating reduced health risks compared to traditional tobacco products.
- Why living past 115 is almost impossible
The article discusses the challenge of living past 115 years despite more people reaching 100. The Limit host Daniel T. Allen investigated through interviews and tests, while Business Insider explored potential lifespan extensions like FDA-approved drugs and Bryan Johnson's 'Don't Die' protocol.
- Long-running recall on popular potato chips brands classified at FDA’s highest risk level
Utz Quality Foods has elevated its ongoing potato chips recall to the FDA’s highest risk level due to Salmonella contamination in a seasoning ingredient. The recall affects popular potato chip brands and is categorized as the most severe by the FDA.
- Utz potato chips issued highest-level FDA recall over salmonella concerns
Utz potato chips issued a highest-level FDA recall due to salmonella concerns. The recall includes specific products: Dirty sour cream and onion chips and Zapp's salt and vinegar chips.
- Potato chip recall elevated to FDA's highest risk level
A potato chip recall has been upgraded to the FDA's highest risk level. Consumers are instructed to discard affected products and seek refunds from Utz.
- STAT+: Roche drug sets new standard for KRAS-driven lung cancer
Roche's drug establishes a new standard for treating KRAS-driven lung cancer. The article is part of a biotech newsletter discussing recent developments in the sector, including FDA regulatory updates and political changes affecting biopharma policy.
- Potato chip recall elevated to FDA's highest risk level
A potato chip recall has been elevated to the FDA's highest risk level. Consumers are advised to discard affected products and contact Utz for refunds.
- Potato chip recall elevated to FDA's highest risk level
A potato chip recall has been elevated to the FDA's highest risk level. Consumers are advised to discard affected products and contact Utz for refunds.
- FDA issues most serious recall alert for potato chip brands over salmonella risk
The FDA has upgraded a recall of several popular potato chip brands to its most serious level due to salmonella contamination risk, affecting an estimated 650,000 bags. Manufacturer Utz issued a voluntary recall for Zapp’s and Dirty potato chips, citing possible salmonella in dry milk powder from a third-party supplier.
- FDA Scientists Raise Peptide Concerns Ahead of Committee Meeting
FDA career scientists have determined there is insufficient evidence to support peptides under consideration for production by compounding, countering HHS Secretary Robert F. Kennedy Jr.'s efforts to expand access to these substances.
- Alibaba to pay US $600M to settle allegations it allowed illegal drug and equipment sales
Alibaba will pay $600 million to the U.S. government to settle allegations that its platforms allowed the sale and import of illegal pharmaceuticals, controlled substances, and related equipment between 2016 and 2024. The settlement resolves claims that Alibaba’s U.S. payment processor failed to prevent unlawful transactions, leading to a non-prosecution agreement with the Justice Department.
- Orca-T Approved to Prevent GVHD After Stem Cell Transplant for Blood Cancers
The FDA approved Orca-T (Tregzi), an allogeneic regulatory T cell-based immunotherapy product combined with hematopoietic stem and progenitor cells and T cells, to prevent graft-versus-host disease (GVHD) in stem cell transplants for hematologic cancers.
- Potato chip recall upgraded to highest FDA risk level over salmonella concerns
The FDA upgraded a potato chip recall to the highest risk level due to salmonella concerns. Utz Quality Foods initially recalled the chips in May.
- Potato chip recall upgraded to highest FDA risk level over salmonella concerns
The FDA upgraded a potato chip recall to the highest risk level due to salmonella concerns. The chips were initially recalled in May by Utz Quality Foods.
- Potato chip recall upgraded to highest FDA risk level over salmonella concerns
Utz Quality Foods upgraded a potato chip recall to the highest FDA risk level due to salmonella concerns. The initial recall was issued in May.
- Potato chip recall upgraded to highest FDA risk level over salmonella concerns
The FDA has upgraded the risk level of a potato chip recall to the highest level due to salmonella concerns. The initial recall was issued in May by Utz Quality Foods.
- 360 Dead in Outbreak; McConnell Still Hospitalized? FDA Rejects Kidney Disease Drug
Congo's Ebola outbreak has confirmed 1,274 cases and 360 deaths, per the CDC. The FDA has rejected a kidney disease drug. Ugandan officials also reported an outbreak, though details are incomplete.
- FDA says Zyn can market its pouches as safer than cigarettes
The FDA has approved Zyn to market its nicotine pouches as safer than cigarettes. The article also mentions STAT’s free health newsletter and a temporary substitution in its editorial team.
- STAT+: FDA approves Orca Bio’s T cell therapy for blood cancer patients
The FDA approved Orca Bio's T cell therapy, Tregzi, which reduces immune reaction risks for blood cancer patients undergoing stem cell transplants. The therapy offers a curative alternative to traditional transplants that carry high risks of chronic graft-versus-host disease.
- Galderma Slumps After FDA Turns Down Botox Rival Relfydess
Galderma's stock declined following the FDA's rejection of Relfydess, a Botox competitor. The decision negatively impacted the company's market performance.
- From Addiction to Law: How a Nashville woman’s death sparked Tennessee’s Nitrous Oxide ban
Kelly Rosenthal's death from nitrous oxide addiction led to Tennessee legislation banning its sale at vape shops. A WSMV4 investigation revealed easy access to nitrous oxide at vape shops, prompting bipartisan support for the Nitrous Oxide Abuse Prevention and Retail Sales Prohibition Act.
- FDA scientists flag concerns with peptides, the trendy molecules RFK Jr. supports
FDA scientists have raised concerns about the lack of evidence for the efficacy and safety of peptides, which are supported by RFK Jr. An FDA panel will consider easing access to peptides later this month despite these concerns.
- Are ZYN nicotine pouches safer than smoking? FDA weighs in
The FDA conducted a survey indicating that ZYN nicotine pouches are the most popular among middle and high school students who use such products. The FDA is evaluating whether ZYN nicotine pouches are safer than smoking.
- Medication used to treat heart failure recalled nationwide
Nearly 1 million bottles of a heart failure medication are being recalled nationwide due to potential contamination with a foreign substance, as reported in an FDA recall alert.
- FDA picks Eli Lilly and Regeneron for program to speed up domestic drug factory reviews
The FDA has selected Eli Lilly and Regeneron for its PreCheck program, which aims to expedite domestic drug factory reviews by assessing facilities during construction. The program could save participating companies up to 14 months in review time.
- FDA expands cheese recall over possible listeria contamination
The FDA has expanded a cheese recall due to possible listeria contamination. Consumers are advised to return the recalled products for a full refund.
- FDA panel on peptides will include experts who promote the unproven chemicals favored by RFK Jr.
The FDA will convene a panel to review the safety of popular peptide injections, with participants including doctors and pharmacists financially tied to the peptide industry. The meeting, part of efforts to reshape health policy under Robert F. Kennedy Jr., will assess peptides like BPC-157 and TB-500, which the FDA has previously warned are unapproved and risky.
- FDA panel on peptides will include experts who promote the unproven chemicals favored by RFK Jr.
The FDA's upcoming panel to review controversial peptide drugs includes health professionals with financial ties to the industry, including clinics and pharmacies promoting unproven peptides. The meeting follows concerns about the safety and regulatory status of substances like BPC-157 and TB-500, which are marketed for wellness purposes but lack scientific validation. Health Secretary Robert F. Kennedy Jr. has publicly supported these peptides.
- A new FDA strategy aims to get medicines to the market faster
The FDA has launched a pilot program with Eli Lilly and Regeneron to accelerate the development and approval of U.S. drug manufacturing facilities by engaging companies during design and construction phases. The initiative aims to reduce delays, improve compliance, and strengthen the domestic pharmaceutical supply chain to reduce reliance on overseas production.
- Eli Lilly, Regeneron among first companies selected for FDA initiative to speed review of new manufacturing facilities
Eli Lilly and Regeneron are among the first seven companies selected by the FDA for its PreCheck Pilot Program, an initiative aimed at accelerating the review of new manufacturing facilities. The program was reported by CNBC.
- FDA Expands Risankizumab Label in Psoriatic Disease
The FDA expanded the indications for risankizumab (Skyrizi) in plaque psoriasis and psoriatic arthritis to include treatment of children 6 years and older. AbbVie announced this update, noting risankizumab is an interleukin (IL)-23 antagonist.