FDA

The FDA approved pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa (Keytruda Qlex) in combination with enfortumab vedotin (Padcev) as perioperative treatment for adults with muscle-invasive bladder cancer. The approval expands the use of a chemo-free therapy in a curative setting for this condition.

Honey packs marketed as natural supplements often contain undeclared pharmaceutical ingredients like sildenafil and tadalafil, posing health risks for consumers, especially those on heart or blood-pressure medications. The FDA has warned about tainted products, emphasizing that 'natural' labeling does not guarantee safety.

The FDA has delayed the deadline for banning electric shock devices. The article also mentions a health insurance cost series and a newsletter signup, but focuses on the FDA's action.

The FDA has approved a gene therapy for sickle cell disease in children as young as 2 years old, expanding access previously limited to those 12 and older. The treatment involves gene-editing a patient's stem cells to produce fetal hemoglobin, offering a potential cure without requiring a donor match.

The FDA recalled 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension eye drops due to a potential foreign substance contamination linked to a manufacturing plant in India.

Lupin Pharmaceuticals is recalling 2.5 million bottles of prescription steroid eye drops due to contamination. The FDA classified the recall as Class II, indicating potential temporary or reversible health effects from using the affected product.

The article poses the question of who will lead the FDA and mentions STAT's free health newsletter, Morning Rounds, while referencing a World Cup match between France and Morocco.

Virginia lawmakers allocated $15 million over two years to expand Medicaid coverage for gene therapy treatments for sickle cell disease. The funding enables Virginia to separately pay for gene therapy drugs and associated care, improving access for Medicaid patients. Sentara-EVMS Comprehensive Sickle Cell Program serves over 200 adults in Hampton Roads, referring eligible patients to VCU Health for gene therapy, which involves a complex, months-long process including chemotherapy and cell infusion.

The FDA has suspended the licence of Mumbai’s Rustom ice cream parlour under the Food Safety and Standards Act following an inspection that revealed serious hygiene deficiencies and regulatory violations.

Costco faces a class-action lawsuit alleging the sale of Orgain Organic Protein Powder containing undisclosed lead, cadmium, and arsenic. Plaintiffs claim the product's packaging and marketing, including USDA Organic certification and 'clean nutrition' language, misled consumers about its safety, despite a Consumer Reports test finding lead levels exceeding concerns. The FDA does not pre-test supplements, leaving consumers reliant on retailers' safety claims.

The FDA approved gene therapy for treating sickle cell disease in children aged 2 and older. A Nashville doctor described the approval as a medical milestone.

Millions of Prednisolone Acetate Ophthalmic Suspension eye drops are being recalled nationwide by the FDA due to potential foreign substances. The medication, used to treat allergies and inflammation, is produced by Lupin.

The FDA approved Trutakna, a kidney disease drug from Vera Therapeutics, for treating IgA nephropathy at an annual price of $425,000. U.K. officials are finalizing a pricing deal with AstraZeneca and Daiichi Sankyo to provide access to Enhertu, a breast cancer drug previously deemed too costly for the U.K. market.

Vera Therapeutics' stock increased following FDA approval of Trutakna, a $425,000-per-year drug targeting BAFF and APRIL proteins for IgA nephropathy. The drug is the first in the U.S. to address both proteins linked to the condition.

Maharashtra CM assures arecanut traders that trucks seized by FDA from Karnataka will be released. Over 50 trucks carrying arecanut were stopped by FDA officials in June.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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 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.

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.

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.

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.

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.

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 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 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.

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.

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.

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.

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.

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.