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FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.

FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.

FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.

Cooperative intermolecular interactions regulate supramolecular polymer assembly

Supramolecular chemistry involves the study of self-assembly of discrete molecules that are used to build large functional structures. Often, these molecules are allowed to self-assemble into one-dimensional polymeric structures (supramolecular polymers or SPs) in a suitable environment, and the dynamic molecular interactions are noted for tweaking the environment and improving the features of the resulting SPs. They are being explored as the next-generation polymeric materials with applications in electronics, soft-robotics, nanofabrication, and biomedical fields.

Chaotic 3D currents form multiple microplastic 'attractors' beneath the ocean surface, study finds

The ocean is saturated with microplastics. While we know the location of the great garbage patches, where plastic particles may accumulate below the ocean surface remains unknown. The vastness of the ocean means particle sampling data are sparse, but modeling how particles aggregate in 3D fluid flows can help determine where to look.

Electron-phonon interactions in crystals found to be quantized by a fundamental constant

A researcher at the Department of Physics at Tohoku University has uncovered a surprising quantum phenomenon hidden inside ordinary crystals: the strength of interactions between electrons and lattice vibrations—known as phonons—is not continuous, but quantized. Even more remarkably, this strength is universally linked to one of the most iconic numbers in physics: the fine-structure constant.

Observations link solar flare pulsations to repeated magnetic reconnection

A new study led by Southwest Research Institute (SwRI) links quasi-periodic pulsations (QPPs) in solar flares to dynamic oscillations in magnetic reconnection, a phenomenon that can drive space weather and affect technology on Earth. This research could help refine traditional solar flare models and provide new insights into the mechanisms driving them.

Mosquito vectors of malaria rapidly develop resistance against new generation insecticides, study finds

More than half a million people, the vast majority being children under the age of 5, die annually due to malaria, with Sub-Saharan Africa as the most highly burdened region. Mosquitoes belonging to the genus Anopheles carry Plasmodium parasites and infect humans, occasionally causing severe symptoms. Control of the mosquito vector by means of insecticides has greatly contributed to malaria prevention so far; nevertheless, these successful efforts are seriously undermined by the rapid development and spread of insecticide resistance in wild Anopheles populations.

Why you feel pressure to adhere to Christmas traditions, and how to reject the ones you don't like

It's December, the weather's turning, and the holidays are fast approaching. You've got to find the perfect gift for your partner, parents or that weird relative you only see once a year. At work, there's the secret Santa for a colleague you barely know, and the office party you'd rather avoid.

You care about fairness at work, so why do you feel like a fake?

Most people care about fairness at work and want to support colleagues who face marginalization—for example, people of color, women and people with disabilities. Our research has found that 76% of employees want to be allies to co-workers who face additional challenges, and 84% value equity. That's in line with a 2025 national survey that found 88% of employees supported employers offering training on how to be more inclusive.

Precision Therapy for Sepsis

Sepsis is a macabre dance between host and pathogen. With development of germ theory by Lister, Semmelweis, Pasteur, and Koch, pathogen eradication was the focus. Only in recent decades, with observations by Roger Bone and others that patients succumbed to sepsis despite successful eradication of the pathogen, did attention swing to the host. It is now well accepted that a hallmark of sepsis is the systemic host immune response to infection that is directly injurious to vital organs. Unfortunately, the response is also extremely complex and highly variable in a way that is not easily appreciated from routine clinical examination or laboratory tests. This clinically elusive heterogeneity in the underlying pathogenesis of sepsis has bedeviled attempts to develop immune modulating therapies, with a litany of failed trials. The great hope is that success will lie in a strategy of precision therapy for sepsis, where a particular host response pattern can be identified swiftly and treated with more targeted interventions. Although ideas abound on how to measure and treat specific host-response patterns, the hope has remained largely theoretical, with little demonstration that it is practical and effective in clinical practice.

New COVID-19 Vaccination Guidelines for Immunocompromised Individuals

The Infectious Diseases Society of America (IDSA) issued a “strong recommendation” for COVID-19 vaccination in immunocompromised individuals based on a “moderate certainty of evidence” in new guidelines. The IDSA panel conducted a literature review of 14 COVID-19 vaccine effectiveness studies published since June 2024, which primarily examined messenger RNA vaccination, in immunocompromised populations.

An Oasis in the Platelet Desert?

A substantial proportion of the global population lacks reliable, timely access to platelet transfusions, largely due to constraints in donor supply and the inherently short shelf life of platelets. Even in high-income countries, including the US, platelet availability remains limited, as an aging donor population is not being sufficiently replenished by younger donors. As a result, the platelet supply is increasingly at risk of failing to meet clinical demand, particularly for cardiac surgery, the management of hypoproliferative thrombocytopenia in oncology patients, and the treatment of patients with acute or chronic bleeding disorders—needs that are all expected to rise as the population ages.

Black hole ejects matter at 20% light speed in sun-like magnetic event

An international team of astronomers, led by SRON, has observed a sudden outburst of matter near the supermassive black hole NGC 3783 at speeds reaching up to 20% of the speed of light. During a 10-day observation, mainly with the XRISM space telescope, the researchers witnessed its formation and acceleration. Scientists often find that these outbursts are powered by strong radiation, but this time the most likely cause is a sudden change in the magnetic field, similar to bursts on the sun that cause solar flares.

Mitotic stopwatch pathway shows how cancer loses its sense of time to avoid stress responses

When cell division (mitosis) takes too long, it can be a sign that something is wrong with the cells, for example, DNA damage or chromosomal instability. That's why our cells come with an innate ability to tell the time, with a stress response known as the mitotic stopwatch pathway activating after prolonged mitosis, and triggering cell cycle arrest, or even cell death.