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AbelZeta's C-CAR168 Receives EMA PRIME Designation for Lupus Treatment

AbelZeta's C-CAR168 Receives EMA PRIME Designation for Lupus Treatment

AbelZeta's C-CAR168 Receives EMA PRIME Designation for Lupus Treatment
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Scholar Rock Updates on Apitegromab MAA Review Amid FDA Inspection Uncertainty

Scholar Rock Updates on Apitegromab MAA Review Amid FDA Inspection Uncertainty

Scholar Rock Updates on Apitegromab MAA Review Amid FDA Inspection Uncertainty
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FDA's Transparency Policy Faces Legal Challenges Amid CRL Publication

FDA's Transparency Policy Faces Legal Challenges Amid CRL Publication

The FDA's policy to publish complete response letters (CRLs) has encountered legal uncertainties, raising concerns among legal experts and industry stakeholders. Initially introduced by former Commissioner Marty Makary in 2025, the policy aimed to enhance transparency for drug developers, investors, and patients. However, the legal foundation of this initiative is under scrutiny, with recent developments indicating a pause and resumption of the policy. Legal experts, including Elizabeth Jungman, a former FDA chief of staff, have highlighted potential legal breaches, as the FDA's regulations consider the existence of an application confidential. The agency is now seeking to amend the Federal Food, Drug, and Cosmetic Act to solidify the policy's legal basis. Despite these efforts, concerns persist about the disclosure of sensitive information, as highlighted in a citizen petition filed by Covington & Burling on behalf of an unnamed drugmaker.
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Zoetis Faces Securities Fraud Lawsuit Over Misleading Statements

Zoetis Faces Securities Fraud Lawsuit Over Misleading Statements

Zoetis Faces Securities Fraud Lawsuit Over Misleading Statements
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Hannah Soyer's Memoir Explores Life with Spinal Muscular Atrophy

Hannah Soyer's Memoir Explores Life with Spinal Muscular Atrophy

Hannah Soyer's Memoir Explores Life with Spinal Muscular Atrophy
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Dermatologists Discuss the Efficacy of Sunscreen Oils in Sun Protection

Dermatologists Discuss the Efficacy of Sunscreen Oils in Sun Protection

Dermatologists Discuss the Efficacy of Sunscreen Oils in Sun Protection
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Taco Bell and Chipotle face a problem bigger than lettuce

Taco Bell and Chipotle face a problem bigger than lettuce

A food safety scandal can disappear from headlines within weeks or follow a restaurant brand for years. Taco Bell is now facing the same question that once challenged Chipotle: How long will customers remember? While they have not been implicated by the FDA in serving the infected lettuce that has ...
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FDA Retracts Cyclospora Contamination Claim Against Taylor Farms

FDA Retracts Cyclospora Contamination Claim Against Taylor Farms

The FDA has retracted its previous claim that Taylor Farms was responsible for a cyclospora outbreak linked to Taco Bell lettuce, stating that the initial test results were a false positive. This reversal follows a re-evaluation of the lettuce sample, which showed no traces of the cyclospora parasite. The initial announcement had led to a recall of Taylor Farms' lettuce and concerns over food safety. The FDA has apologized to Taylor Farms for the error, and the company has confirmed that the implicated product was not part of its current recall.
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Taylor Farms' Cyclospora Investigation Continues Despite False Positive Test Result

Taylor Farms' Cyclospora Investigation Continues Despite False Positive Test Result

The FDA has confirmed that a sample of lettuce from Taylor Farms, which initially tested positive for the cyclospora parasite, was a false positive. Despite this, the FDA's investigation into the outbreak of cyclosporiasis, which has affected over 1,600 people across 34 states, continues to focus on Taylor Farms' operations in central Mexico. The outbreak has been linked to iceberg lettuce supplied to Taco Bell restaurants in several states. Taylor Farms has voluntarily recalled all iceberg lettuce from the implicated region. The CDC has identified the lettuce as a source of the outbreak, which has led to numerous hospitalizations but no deaths. The complexity of testing for cyclospora has been highlighted, with experts noting the challenges in accurately detecting the parasite.
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Brain Implant Enables Paralyzed Man to Regain Movement and Sensation

Brain Implant Enables Paralyzed Man to Regain Movement and Sensation

Keith Thomas, who became paralyzed from the chest down after a diving accident in 2020, has regained significant movement and sensation thanks to a groundbreaking brain implant. Developed by Professor Chad Bouton's team at the Feinstein Institutes for Medical Research, the implant system, known as a 'double neural bypass,' allows Thomas to perform tasks such as feeding himself and feeling his dog's fur. The system works by reading Thomas's brain signals and routing them directly to his arm and hand muscles, while sensors on his fingers send touch feedback to his brain. After 35 weeks of training, Thomas's right-arm strength increased by 86% and his left by 62%. Remarkably, some of these improvements have persisted even when the device is turned off, with gains still present after more than two years.
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Gene Therapy Shows Promise in Reversing Fragile X Syndrome Traits

Gene Therapy Shows Promise in Reversing Fragile X Syndrome Traits

Gene Therapy Shows Promise in Reversing Fragile X Syndrome Traits
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Cyclospora Outbreak Prompts Major Retailers to Recall Iceberg Lettuce Across U.S.

Cyclospora Outbreak Prompts Major Retailers to Recall Iceberg Lettuce Across U.S.

A Cyclospora outbreak linked to contaminated iceberg lettuce has led to widespread recalls by major retailers and restaurant chains in the U.S. Federal investigators are working to trace the source of the contamination, which has resulted in over 1,644 illnesses and 94 hospitalizations across five states. The outbreak has been traced to shredded iceberg lettuce supplied by Taylor Farms, prompting the company to recall all lettuce sourced from central Mexico. Retailers like Walmart and Taco Bell have removed affected products as a precautionary measure, while federal officials continue to investigate the outbreak.