All articles tagged with #biologics
Originally Published 9 days ago — by Nature
In 2025, the FDA approved 46 new therapeutic agents, including a diverse range of modalities such as biologics, kinase inhibitors, and gene therapies, with cancer remaining the most common therapeutic area. The year was marked by policy changes, staffing challenges, and the launch of new approval pathways, reflecting a tumultuous but innovative period for drug development.
Originally Published 2 months ago — by fda.gov
The FDA announced new measures to streamline the development and approval of biosimilar drugs, aiming to lower costs and increase access to affordable biologic treatments by simplifying testing requirements and promoting interchangeability, thereby fostering market competition and reducing healthcare expenses.
Originally Published 3 months ago — by Endpoints News
The FDA's biologics center has released new draft guidances aimed at helping developers streamline the creation of innovative cell and gene therapies for small patient populations.
Originally Published 5 months ago — by statnews.com
Vinay Prasad is returning to the FDA to resume his role overseeing biologics, including vaccines and gene therapy, after a brief departure amid tensions related to a Duchenne muscular dystrophy gene therapy and political criticisms.
Originally Published 1 year ago — by Endpoints News
Peter Marks, the FDA's chief of vaccines and biologics, announced at the Jefferies London Healthcare Conference that he intends to remain in his position as long as he is welcome, despite any incoming changes.
Originally Published 2 years ago — by Nature.com
The FDA approved 55 new drugs in 2023, marking a significant increase from the previous year and setting a 10-year rolling average high. Oncology led with 24% of the approvals, followed by neurology. Notable approvals included the first CRISPR–Cas9-based gene editing product, two RSV vaccines, and a burst of gene therapies. AstraZeneca's capivasertib became the first AKT inhibitor approved for breast cancer, and several first-in-class cancer therapies were greenlit. In neurology, Biogen and Ionis's tofersen received accelerated approval for SOD1-mutated ALS, and Eisai and Biogen's lecanemab was approved for Alzheimer's disease. The approvals spanned various modalities, including nucleotide-based therapeutics and T-cell engaging bispecific antibodies.
Originally Published 2 years ago — by Nature.com
Scientists have developed a method to genetically encode multiple functionalities into extracellular vesicles (EVs) for targeted delivery of biologics to T cells. EVs, such as exosomes, have shown promise as vehicles for therapeutic cargo delivery, but their targeting capabilities have been limited. By engineering EVs to express specific ligands or antibodies on their surface, researchers were able to enhance their binding and uptake by T cells. This approach could potentially improve the efficacy of T cell-based therapies and expand their applications in treating various diseases.
Originally Published 2 years ago — by KSHB 41 Kansas City News
The Kansas City area has been chosen by the Biden administration as one of 31 technology hubs in the United States, with the aim of promoting innovation and job creation. The Kansas City Inclusive Biologics and Biomanufacturing Tech Hub (KC BioHub) will focus on the development and manufacturing of vaccines and related technologies. Led by BioNexus KC, the nonprofit organization will have the opportunity to receive up to $75 million in federal funding, attract additional investments, and expand the development of cutting-edge medicines and vaccines. The tech hubs program was established through bipartisan legislation, allocating $10 billion over five years.
Originally Published 2 years ago — by Medscape
New German guidelines on the management of asthma aim to shift the paradigm from relying on inhalers to a symptom-prevention approach. The guidelines emphasize the use of anti-inflammatory therapy as the primary treatment option, with inhaled glucocorticoids being the cornerstone of therapy. Allergen immunotherapy and biologics are also effective anti-inflammatory treatments. The guidelines recommend the use of biomarkers, such as eosinophils, IgE levels, and the FeNO test, for diagnosis. Biologics are highlighted as highly effective for severe asthma cases, and a diagram is provided to help choose the most suitable biologic for each patient. The guidelines also address asthma management in children and adolescents, including advice on career choices and the interrelation between asthma and mental health.
Originally Published 2 years ago — by WIRED
Researchers at Rice University have developed a drug-delivery system that uses microparticles to release medication in timed delays that can span days or even weeks. The system involves injecting hundreds of tiny microplastic particles, each encapsulating a small dose of a drug, into the body. By adjusting the molecular weight of the polymer used for each capsule, the scientists can control how fast they erode and release medication. The team envisions designing a library of these particles that can mimic different dosing schedules: daily, weekly, monthly, or something in between, depending on the patient.