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FDA publishes full texts of response letters to drug applications

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  • 2025-07-11 17:20 event
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FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from 2020 to 2024.

34. Simply 'sprinkling' a fluorescent probe can quickly show active brain synapses

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There are few scientific methods more elegantly simple than "just sprinkle it on top." Researchers at Tohoku University and Nagoya University developed a fluorescent probe that can quickly show synapses, the connection points between brain cells.

35. Dealing with extreme heat is a full-time job for parents of young kids—and their schools

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According to survey data from the Stanford Center on Early Childhood, families—across all income levels, races, ethnicities and regions—are increasingly considering how extreme weather conditions affect them. More than half of families with young children across the state are worried about its effects, according to data from the center's RAPID Survey Project, which examines early childhood and family well-being. Heat, in particular, is a significant concern.

36. Mathematical model reveals how humans store narrative memories using 'random trees'

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Humans can remember various types of information, including facts, dates, events and even intricate narratives. Understanding how meaningful stories are stored in people's memory has been a key objective of many cognitive psychology studies.

37. Olorofim Phase IIb trial shows efficacy in invasive fungal disease for patients with limited treatment options

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Researchers from KU Leuven, the University of California Davis Medical Center, the University of Cologne, and over 20 collaborating institutions report that the antifungal olorofim demonstrated efficacy and tolerability in patients with invasive fungal disease who had exhausted most other treatment options.

38. Toxic metals linked to impaired growth in infants in Guatemala

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Research led by the University of Arizona Health Sciences found a potential link between growth problems among infants and high levels of toxic metals and other elements in the breast milk of Mayan women in Guatemala's Lake Atitlán watershed region.

39. US measles case count hits 33-year high—and Texas' outbreak is to blame, suggests vaccine expert

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Already in 2025, the United States has reported more measles cases than in any full year since the early '90s, according to federal data. And that record-setting case count has been driven by a massive outbreak that began in Texas.

40. Study findings help hone precision of proven cardiovascular disease risk tool

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Cardiovascular disease (CVD) risk prediction models have improved the ability to stratify adults across the CVD risk spectrum. Researchers at Sutter Health and colleagues at Stanford University tested the performance of the American Heart Association's Predicting Risk of CVD Events (PREVENT) equations in the six largest Asian subgroups as well as in Mexican and Puerto Rican Hispanic subgroups.

41. Major progress in fertility preservation after treatment for cancer of the lymphatic system

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Young patients with advanced Hodgkin's lymphoma, a cancer of the lymphatic system, now have a better chance of having their own children after treatment.

42. Attending events is the ticket to happiness, study suggests

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New research led by the University of South Australia has found that frequently attending in-person events can significantly boost well-being.

43. FDA publishes full texts of response letters to drug applications

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The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from 2020 to 2024.

44. Weekly injection offers steady Parkinson's medication, reducing need for daily pills

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A new weekly injectable drug could transform the lives of more than eight million people living with Parkinson's disease, potentially replacing the need for multiple daily tablets.

45. Premenstrual symptoms linked to increased risk of cardiovascular disease

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Women diagnosed with premenstrual symptoms have a slightly increased risk of developing cardiovascular disease later in life. This is shown by a new study from Karolinska Institutet published in Nature Cardiovascular Research.

46. Smarter flow simulation model for analyzing blood flow in brain aneurysms improves efficiency and accuracy

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To simulate blood flow inside brain aneurysms, researchers from Japan have developed a computational method that combines 4D flow MRI, computational fluid dynamics, and data assimilation, which provides greater accuracy and efficiency. By focusing only on the aneurysm region, this approach significantly reduces computational cost while improving flow estimation. When validated on patient data, it outperforms conventional models—offering a practical tool for patient-specific risk assessment and treatment strategies.

47. CDC finds nearly 1 in 3 US youth have prediabetes, but experts question scant data

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A new federal estimate shows a rise in prediabetes among American adolescents, a finding that is spurring concerns about the health of U.S. children—and the way Trump administration health officials are conducting research and communicating information, experts said.

48. Underserved youth less likely to visit emergency department for concussion in Ontario, study finds

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A new study finds socioeconomic disparities in rates of emergency department (ED) visits for concussion among children and youth.

49. 'Molecular shield' placed in the nose may soon treat common hay fever trigger

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Approximately 40% of the European population are allergic to pollen, and their symptoms cause an estimated loss of 100 million school and workdays every year.

50. Children's social care involvement common to nearly third of UK mothers who died during perinatal period: Study

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The involvement of children's social care services was a common factor in nearly a third of UK maternal deaths occurring during, or within a year of, pregnancy between 2014 and 2022, finds research published in BMJ Medicine.

51. Ethnic minority and poorer children more likely to die in intensive care, research finds

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Children from ethnic minority backgrounds and those living in areas with higher levels of child poverty were more likely to die in intensive care than white children and those from the least deprived areas.

52. Being consistently physically active in adulthood may extend lifespan

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Being consistently physically active in adulthood is linked to a 30–40% lower risk of death from any cause in later life, while upping levels from below those recommended for health is still associated with a 20–25% lower risk, finds a pooled data analysis of the available evidence, published online in the British Journal of Sports Medicine.

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