An increase in total drug (small molecules and biologics) approvals by the Food and Drug Administration (FDA) was seen in 2023 compared with the previous year. Cancer remained the disease most targeted by monoclonal antibodies (mAbs), followed by autoimmune conditions. Our data reveal the prevalence of approvals for biologics even during years when the total number of authorizations was low, such as in 2022. Over half the drugs that received the green light in 2023 benefited from expedited programs, as the incidence of many diseases increased. In addition, over half of the biologics approved received Orphan Drug Designation from the FDA. This narrative review delves into details of the most significant approvals in 2023, including mAbs, enzymes, and proteins, explaining their mechanisms of action, differences from previous drugs, placebo, and standards of care, and outcomes in clinical trials. Given the varying number of drugs authorized annually by the U.S. health authority, this review also examines the limits of external influences over the FDA′s decisions and independence regarding drug approvals and withdrawals.

Despite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large space in the pipeline of the pharmaceutical industry and boosted the innovation portfolio and arsenal of therapeutic compounds available. Here, we report on biological drug approvals by the US Food and Drug Administration (FDA) from 2015 to 2021. The number of drugs included in this class grew over this period, totaling 90 approvals, with an average of 13 authorizations per year. This figure contrasts with previous periods, which registered between 2 and 8 approvals per year. We highlight the great potential and advantages of biological drugs. In this context, these therapeutics show high efficacy and high selectivity, and they have brought about a significant increase in patient survival and a reduction of adverse reactions. The development and production of biopharmaceuticals pose a major challenge because these processes require cutting-edge technology, thereby making the drugs very expensive. However, we believe that, in the near future, biological medicines will be more accessible and new drugs belonging to this class will become available as new technologies emerge. Such advances will enhance the production of these biopharmaceuticals, thereby making the process increasingly profitable and less expensive, thereby bringing about greater availability of these drugs.

The year 2022 witnessed the control of the COVID-19 pandemic in most countries through social and hygiene measures and also vaccination campaigns. It also saw a decrease in total approvals by the U.S. Food and Drug Administration (FDA). Nevertheless, there was no fall in the Biologics class, which was boosted through the authorization of 15 novel molecules, thus maintaining the figures achieved in previous years. Indeed, the decrease in approvals was only for the category of small molecules. Monoclonal antibodies (mAbs) continued to be the drug class with the most approvals, and cancer remained the most targeted disease, followed by autoimmune conditions, as in previous years. Interestingly, the FDA gave the green light to a remarkable number of bispecific Biologics (four), the highest number in recent years. Indeed, 2022 was another year without the approval of an antimicrobial Biologic, although important advancements were made in targeting new diseases, which are discussed herein. In this work, we only analyze the Biologics authorized in 2022. Furthermore, we also consider the orphan drugs authorized. We not only apply a quantitative analysis to this year’s harvest, but also compare the efficacy of the Biologics with those authorized in previous years. On the basis of their chemical structure, the Biologics addressed fall into the following classes: monoclonal antibodies; antibody-drug conjugates; and proteins/enzymes.

Advances in drug development continue to play a critical role in addressing diseases, including those with unmet medical needs. In 2024, the FDA approved 50 novel drugs, 16 of which were biologics. For context, during the first half of 2024 alone, the agency approved six biologics. By mid-2025, six additional biologics have received the green light, indicating that the pace of approvals of this class of drugs this year may be on par with 2024. This paper analyzes all biologics that received FDA authorization in 2024, examining their mechanisms, clinical trials, and expedited review pathways. Key approvals included the highest number of monoclonal antibodies (mAbs) since 2015 (13 mAbs, 6 indicated for oncology), while no antibody–drug conjugates were authorized—continuing with the trend in 2023. In addition, a new chimeric mAb has been approved since the last chimeric mAb approved in 2022, and a new mAb for Alzheimer’s disease. Nine biologics are first-in-class therapies, while ten received Orphan Drug Designation. The biologics considered herein fall into the categories of mAbs and proteins.

Pharmaceutical interventions play a vital role in managing various conditions, including weight-related issues such as obesity. In this context, lifestyle changes are often challenging to maintain,

Objetivo: A barreira hematoencefálica (BHE) é um protetor natural do sistema nervoso central (SNC), mas também pode ser um fator limitante para fármacos devido a sua alta seletividade. Uma maior permeabilidade e menor seletividade da BHE não mostrou ser a resposta para melhorar os tratamentos medicamentosos de pacientes com doença de Alzheimer (DA) e outras demências, pois dados encontrados apontam que uma maior permeabilidade pode ser fator contribuinte para o avanço de demências. O presente trabalho busca trazer os últimos avanços no tratamento da DA e fomentar a discussão sobre tais tratamentos e avanços, abordando especificamente a BHE. Abordaremos os aspectos fisiológicos da BHE relacionando-os com os fármacos usados para o tratamento, abordando também as características dos fármacos que dificultam atravessar a BHE. Buscou-se realizar uma revisão principalmente da literatura estrangeira, trazendo os últimos avanços para o tratamento da DA, visto que existe uma quantidade maior de material sobre a BHE em material em inglês do que em português. Métodos: Foi realizada uma revisão da literatura utilizando os seguintes bancos de dados: PubMed, Scielo, Google acadêmico. O período de abrangência usado nas pesquisas foi entre 2005 e 2020. Buscamos revisar também ensaios clínicos atualmente registrados, que buscam estudar a BHE e a DA, na base de dados norte-americana clinicaltrials.gov. Revisamos também capítulos que abordavam a BHE de três livros, sendo um livro de fisiologia e dois livros de farmacologia. Conclusão: Conclui-se que a BHE não pode ficar de fora de pesquisas para DA e outras demências devido a sua extrema importância. Observou-se que a permeabilidade da BHE pode tanto beneficiar os pacientes futuramente se for mensurada e controlada, como pode também prejudicar e colaborar com o avanço das demências se não for totalmente compreendida. A perspectiva para o tratamento da DA sob este prisma da BHE mostrou-se positiva, devido a um aumento encontrado de novas abordagens para tratar, prevenir e compreender a DA.