FDA has determined the regulatory review period for ALFAPUMP, which is relevant for a patent extension application. This notice is part of the legal requirements for patent claims related to the medical device.

FDA has determined the regulatory review period for COBENFY, which is necessary for the patent extension application process. This notice is part of the legal requirements for patent claims related to human drug products.

FDA has released a draft guidance on 'E22 General Considerations for Patient Preference Studies,' aimed at standardizing the design and analysis of such studies. This guidance, developed with the International Council for Harmonisation, will enhance the incorporation of patient preferences in drug development once finalized.

The FDA has issued a 10-year debarment order against Paul Zachary Lamberty for importing misbranded drugs, following his felony convictions for conspiracy and fraud. This action underscores the agency's commitment to maintaining drug safety and integrity in the U.S. market.

FDA amends regulations to expand the use of spirulina extract as a color additive in human foods, excluding infant formula and certain USDA-regulated foods. This change allows for broader application of this natural colorant in the food industry.

FDA amends regulations to allow the safe use of beetroot red as a color additive in human foods, excluding certain products like infant formula and USDA-regulated items. This change aligns with current good manufacturing practices.

A recent study highlights primary pulmonary MALT lymphoma as a rare condition often misdiagnosed due to its pneumonic presentation. This research underscores the need for increased awareness and accurate diagnosis of this rare lymphoma subtype.

A new study presents a weakly supervised transformer model designed for diagnosing rare diseases and subphenotyping using electronic health records (EHRs). The research focuses on pulmonary case studies, potentially enhancing diagnostic accuracy in rare disease identification.

A new study presents a method for the single-round evolution of RNA aptamers using GRAPE-LM, potentially enhancing the development of targeted therapies. This research could lead to advancements in precision medicine for various conditions.

A systematic review and meta-analysis reveals the global prevalence of peripheral neuropathy in cancer patients post-chemotherapy. This study highlights the significant impact of chemotherapy on nerve health, emphasizing the need for better management strategies.

The FDA has issued a permanent debarment order against Matthew Teltser, prohibiting him from providing services related to any approved or pending drug product applications. This decision follows his felony conviction related to drug development and approval processes.

FDA has determined the regulatory review period for BEQVEZ, which is necessary for a patent extension application. This notice is part of the legal requirements for patent claims related to human biological products.

A recent study explores the resistance mechanisms of trastuzumab deruxtecan in HER2-amplified versus HER2-low breast cancer. Understanding these differences could inform treatment strategies and improve patient outcomes.

A recent study highlights the significant cardiovascular morbidity and mortality associated with Fabry disease. This research underscores the need for increased awareness and targeted interventions for patients suffering from this rare condition.

A study analyzing stillbirths at a Shanghai maternity center from 2014 to 2024 reveals trends in sex distribution and gestational age-specific risks. The findings contribute to understanding factors influencing stillbirth rates.

A five-case series highlights venous adventitial cystic disease of the lower extremities, which can mimic deep vein thrombosis. This research contributes to the understanding of this rare condition and its clinical implications.

A new study published in PubMed explores the natural history of patients with histologically proven acute eosinophilic myocarditis. This research provides insights into the disease's progression and patient outcomes, contributing to the understanding of this rare condition.

A case study highlights the presence of phagocytic mesothelial cells in pericardial effusion after allogeneic peripheral blood stem cell transplantation for chronic active Epstein-Barr virus infection. This research provides new insights into the cytomorphological and immunocytochemical characteristics associated with this rare condition.

A recent study discusses the challenges of ovarian stimulation and oocyte cryopreservation in a patient with Hirata syndrome, highlighting the complexities in assisted reproduction for this rare condition. The findings may inform future clinical practices in fertility preservation.

A new study presents a cross-species self-supervised transfer learning approach for pulmonary lobe segmentation in nonhuman primates. This research could enhance imaging techniques and improve understanding of pulmonary diseases.