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Jazz Pharmaceuticals Acquires Actio Biosciences to Enhance Epilepsy Treatment Portfolio

Jazz Pharmaceuticals Acquires Actio Biosciences to Enhance Epilepsy Treatment Portfolio

Jazz Pharmaceuticals Acquires Actio Biosciences to Enhance Epilepsy Treatment Portfolio

FDA Approvals Propel Cellular Gene Therapy Forward

FDA Approvals Propel Cellular Gene Therapy Forward

The FDA has approved over 40 cellular and gene therapy products, marking significant progress in the field. Recent approvals include treatments for rare genetic disorders and advancements in CAR T-cell therapy for cancer. The regulatory landscape is evolving to facilitate faster access to these therapies, which aim to provide curative solutions rather than just symptom management. The focus is on precision medicine, targeting the root causes of diseases with advanced genetic tools.

HexemBio Secures $10.4M Seed Funding to Advance Blood Stem Cell Rejuvenation

HexemBio Secures $10.4M Seed Funding to Advance Blood Stem Cell Rejuvenation

HexemBio Secures $10.4M Seed Funding to Advance Blood Stem Cell Rejuvenation

FDA Approves Pluvicto for Expanded Use in Metastatic Prostate Cancer

FDA Approves Pluvicto for Expanded Use in Metastatic Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved Pluvicto, a radioligand therapy developed by Novartis, for use in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). This approval is based on the Phase III PSMAddition trial, which demonstrated that Pluvicto, in combination with standard care, significantly reduces the risk of disease progression or death. The therapy is now available for use across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population. This marks a significant advancement in the treatment landscape for mHSPC, offering a new precision approach for early intervention.

Hims & Hers' shift to branded obesity drugs drives wider quarterly loss

Hims & Hers' shift to branded obesity drugs drives wider quarterly loss

By Sneha S K and Amina Niasse NEW YORK, Aug 10 (Reuters) - Hims & Hers Health posted a wider-than-expected second-quarter loss on Monday as the telehealth company's shift to branded weight-loss drugs drove up costs, sending its shares down 6% in extended trading.

Cyclospora Outbreak in U.S. Linked to Mexican-Grown Iceberg Lettuce

Cyclospora Outbreak in U.S. Linked to Mexican-Grown Iceberg Lettuce

A Cyclospora outbreak in the United States has been linked to Mexican-grown iceberg lettuce, affecting five states and resulting in 1,644 confirmed illnesses and 94 hospitalizations. The outbreak has been traced back to a single supplier, although the supplier's name has not been publicly disclosed. Taco Bell locations in Indiana, Kentucky, Michigan, Ohio, and West Virginia have been identified as points of exposure. The FDA and CDC are actively investigating the outbreak, with Taco Bell ceasing to source lettuce from the implicated supplier. The outbreak highlights the challenges in tracing foodborne illnesses and the importance of rapid response to prevent further spread.

Oncology's Next Challenge: Ensuring Equitable Delivery of Innovative Cancer Treatments

Oncology's Next Challenge: Ensuring Equitable Delivery of Innovative Cancer Treatments

Oncology's Next Challenge: Ensuring Equitable Delivery of Innovative Cancer Treatments

Hims & Hers raises annual revenue forecast on strong subscriber growth

Hims & Hers raises annual revenue forecast on strong subscriber growth

NEW YORK, Aug 10 (Reuters) - Hims & Hers Health on Monday raised its annual revenue forecast and said it beat second-quarter revenue estimates, as the telehealth company benefited from an increase in subscribers and expanding its personalized healthcare offerings.

Latham Watkins Advises Alkeus Pharmaceuticals on Acquisition by Tarsus Pharmaceuticals

Latham Watkins Advises Alkeus Pharmaceuticals on Acquisition by Tarsus Pharmaceuticals

Latham Watkins Advises Alkeus Pharmaceuticals on Acquisition by Tarsus Pharmaceuticals

Nashville Shoppers Turn to Local Farmers Amid Food Safety Concerns

Nashville Shoppers Turn to Local Farmers Amid Food Safety Concerns

In Nashville, recent food recalls have prompted shoppers to seek out local produce as a safer alternative. The FDA has issued warnings about potential Salmonella contamination in jalapeños and a Cyclospora outbreak linked to lettuce. These concerns have led consumers like Billie Austin to discard store-bought jalapeños and turn to local farmers for fresh produce. Farmers at the Nashville Farmers Market, such as Troy Smiley, have noticed an increase in customer inquiries about the safety of their products. Smiley attributes the problem to the processing and shipping practices of mass-produced food and welcomes the increased attention from consumers.

At-Home HPV Tests Gain FDA Approval, Offering New Screening Options

At-Home HPV Tests Gain FDA Approval, Offering New Screening Options

The FDA has authorized the first at-home self-collection device for cervical cancer screening, which tests for high-risk strains of Human Papillomavirus (HPV). This development comes amid a decline in cervical cancer screenings in the U.S., with rates dropping from 47% in 2019 to 41% in 2023. The at-home test is designed to increase accessibility, particularly for women in rural areas who are less likely to receive regular screenings. While the test offers a convenient option for those who avoid traditional screenings, it is not a substitute for in-office exams. The at-home kit cannot perform the comprehensive pelvic and clinical exams necessary to detect other potential health issues. It is intended as a bridge to care for women who are not being screened at all.

FDA to Review Galleri Test for Early Cancer Detection at Upcoming Advisory Meeting

FDA to Review Galleri Test for Early Cancer Detection at Upcoming Advisory Meeting

The FDA has announced a meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to discuss the premarket approval application for the Galleri test by GRAIL, Inc. Scheduled for September 23, 2026, the meeting will evaluate the test's ability to detect cancer-specific methylation patterns in cell-free DNA from blood samples. The Galleri test aims to screen for multiple types of cancer in adults over 50 and predict the origin of detected cancer signals. The meeting will be open to public comment, allowing stakeholders to provide input on the test's potential approval.