2,090 Results Found

(1) Background: Drug development in oncology is changing rapidly. The aim of the present study was to provide an insight into the features of anti-tumor drugs approved in Europe; (2) Methods: We included all the indications for solid tumors issued by...

Precision medicine is essential for the modern care of a patient with cancer. Comprehensive molecular profiling of the tumor itself is necessary to determine the presence or absence of certain targetable abnormalities or biomarkers. In particular, lu...

Every countrywide reform can always have specific opponents and fans as the changes make people leave their comfort zone. As an example, we have chosen a Ukrainian decentralization reform. Although this local self-government reform can be considered...

Increasing gabapentinoid use has raised concerns of misuse and abuse in the United States (US). Little is known about the characteristics of gabapentinoid use in general clinical practice over time. This cross-sectional study used data from the Natio...

Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated re...

Small interfering RNA (siRNA)-based medications offer the ability to target previously undruggable targets and have now received FDA approval in five instances for orphan or uncommon diseases. The current siRNA “-sirans” are directed towa...

Cancer is associated with higher morbidity and mortality and is the second leading cause of death in the US. Further, in some nations, cancer has overtaken heart disease as the leading cause of mortality. Identification of molecular mechanisms by whi...

Background: The large-scale utilization of immunoglobulins in patients with inborn errors of immunity (IEIs) since 1952 prompted the discovery of their key role at high doses as immunomodulatory and anti-inflammatory therapy, in the treatment of IEI-...

For well over 30 years, the botulinum neurotoxin (BoNT) has been used for a large number of indications, some of which however have not been licensed. Admittedly, approval varies in many countries and this permits a large spectrum for evaluation. Thu...

Since its first approval by the Food and Drug Administration in 1989 for strabismus, botulinum toxin indications of use have been widely expanded. Due to its anticholinergic properties, this toxin is currently approved in adult patients for the treat...

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, th...

Neonates continue to be treated with off-label or unlicensed drugs while in hospital. However, some medications that have previously been used in adults underwent clinical testing and licensure for use with a different indication in the neonatal and...

Since 1980, the US Congress has passed legislation providing several incentives to encourage the development and regulatory approval of new drugs, particularly antibiotics. We assessed long-term trends and characteristics of approvals and discontinua...

Once a solid organ transplantation (SOT) has been performed, it is necessary to prescribe immunosuppressant medication to prevent graft rejection. This task has the peculiarity that many of these drugs do not have specific indications for transplant...

Introduction: Advancements in oncology have revolutionized cancer treatment, with new drugs being approved at different rates worldwide. Our objective was to evaluate the approval of new oncological drugs for solid tumors by the Food and Drug Adminis...

Background/Objectives: Hyoscine butylbromide (HBB) is a spasmolytic drug classified as indispensable by the World Health Organization. While mostly used in adults, it is also approved for use in adolescents and children aged 6 years and older. We hav...

Psychiatric disorders are a major cause of illness in the world. Unfortunately, many patients are resistant to treatment and present serious complications. Schizophrenia is refractory to treatment in about one-third of patients. Antidepressants are e...

In 2025, the FDA approved 46 novel drugs, including four TIDEs (one peptide, three oligonucleotides, and one antibody drug conjugate containing peptide as a payload). The three approved oligonucleotide therapeutics—fitusiran, donidalorsen, and...

While mental health services for children are increasing, few psychiatric drugs have been approved for such use. We analyzed claim data from 19,557 South Korean pediatric and adolescent patients (<20 years) who were diagnosed with schizophrenia, b...

Human immunodeficiency virus 1 (HIV-1) is the most prevalent human retrovirus. Recent data show that 34 million people are living with HIV-1 worldwide. HIV-1 infections can lead to AIDS which still causes nearly 20,000 deaths annually in the USA alon...

2019 has been an excellent year in terms of peptides and oligonucleotides (TIDES) approved by the FDA. Despite the drop in the number of total drugs approved by the FDA in 2019 in comparison with 2018 (48 vs. 59), the total number of TIDES authorized...

Purpose: We aimed to evaluate the rate of usage and the kind of patient-reported outcome (PRO) claims in orphan drug approvals from the European Medicines Agency (EMA) dated between 1/1/2012 and 31/12/2016 and to compare them to those from the US Foo...

Bovine anaplasmosis, caused by the intracellular rickettsial pathogen Anaplasma marginale, is the most prevalent tick-transmitted disease of cattle worldwide. In the U.S., tetracycline antimicrobials are commonly used to treat and control anaplasmosi...

Background: The introduction of new vaccines has been delayed in some countries in the Asia-Pacific region, which has led to delays in accessing vaccines for target patients. However, the approval lag of vaccines in the Asia-Pacific region has not be...

Background: Psychiatric patients are subjected to considerable stigmatization, in particular, because they are considered aggressive, uncontrollable, and dangerous. This stigmatization might influence the approval of coercive measures in psychiatry b...

Despite sufficient supply, <25% of the population in sub-Saharan Africa has received at least one dose of COVID-19 vaccine. Vaccine mandates have previously been effective in increasing vaccine uptake. Attitudes to COVID-19 vaccine mandates and va...

There is an increasing interest in the therapeutic use of cannabis worldwide, with a number of cannabinoid-derived drugs currently approved by the Food and Drug Administration (FDA) for certain indications. This study was conducted via a printed ques...

While vaccine acceptance changes over time, and factors determining vaccine acceptance differ depending on disease and region, limited studies have evaluated vaccine acceptance in Nepal. We conducted an online, cross-sectional study to assess COVID-1...

(1) Background: Diabetes mellitus is a significant public health problem. Macrovascular complications (stroke, acute myocardial infarction (AMI) and lower limb amputations (LLAs) represent the leading cause of morbi-mortality in DM. This work aims to...

Since 1955, a total of 12 peptide-based drugs with antimicrobial or antifungal properties have received approval from the Food and Drug Administration (FDA). Peptides present a promising opportunity to address serious infections that may be challengi...

In addition to classic small-molecule drugs and modern protein-based biologics, an intriguing class of medicines is the therapeutic oligonucleotides. Most approved drugs in this category are antisense oligomers or those acting via RNA interference, b...

In the United States, the Food and Drug Administration (FDA) is the regulatory authority with the responsibility to evaluate scientific data included in each vaccine’s prescribing information (e.g., safety, indication(s) for use, and dosing sch...

Background: Janus kinase (JAK) inhibitors represent a novel class of oral therapies showing efficacy in treating ulcerative colitis (UC) and Crohn’s disease (CD), challenging conventional treatment paradigms. Summary: This review provides an ov...

Repurposing drugs by uncovering new indications for approved drugs accelerates the process of establishing new treatments and reduces the high costs of drug discovery and development. Metal complexes with clinically approved drugs allow further oppor...

Dostarlimab (JEMPERLI) is a PD-1 monoclonal antibody for the treatment of adult patients, with mismatch repair deficient (dMMR), recurrent or advanced endometrial cancer that has progressed on or following prior therapy with a platinum-containing reg...

Antibiotic resistance is a critical problem that results in a high morbidity and mortality rate. The process of discovering new chemotherapy and antibiotics is challenging, expensive, and time-consuming, with only a few getting approved for clinical...

Background/Objective: Objective response rate (ORR) is a surrogate endpoint frequently employed in early-phase clinical trials of anticancer agents for the treatment of solid tumors. Assessments of ORR by local investigators tend to be influenced by...

At every juncture in history, the design and identification of new drugs pose significant challenges. To gain valuable insights for future drug development, we conducted a detailed analysis of New Molecular Entitiy (NME) approved by the Food and Drug...

A total of nine TIDES (pepTIDES and oligonucleoTIDES) were approved by the FDA during 2023. The four approved oligonucleotides are indicated for various types of disorders, including amyotrophic lateral sclerosis, geographic atrophy, primary hyperoxa...

Background: Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs’ benefits and risks. Objective: We sought to assess the usage of patient-r...

Dysregulation of the MET tyrosine kinase receptor is a known oncogenic driver, and multiple genetic alterations can lead to a clinically relevant oncogenesis. Currently, a number of drugs targeting MET are under development as potential therapeutics...

Cannabis is the most commonly used illicit substance worldwide. Recent years have seen an increase in cannabis consumption, and with new approvals and therapeutic indications, there are challenges in minimizing the risks and interactions between cann...

Breast cancer represents the first cause of cancer worldwide and the leading cause of cancer mortality for women. Therefore, new therapies are needed to improve the prognosis of women diagnosed with this disease. In this review, we summarize the new...

Despite reliable evidence of adverse drug effects, the substantially increased prescription rates of proton pump inhibitors (PPIs) remain at a high level. This study analyzed the appropriateness of PPI prescriptions among residents of nursing homes i...

We studied the overview of drug discovery and development to understand the recent trends and potential success factors of interorganizational collaboration by reviewing 1204 transactions performed until 2019 for 107 anticancer drugs approved by the...

In 2016, the American Academy of Neurology (AAN) published practice guidelines for botulinum toxin (BoNT) in the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. This article, focusing on dystonia, provides context for t...

With the COVID-19 pandemic behind us, the U.S. Food and Drug Administration (FDA) has approved 55 new drugs in 2023, a figure consistent with the number authorized in the last five years (53 per year on average). Thus, 2023 marks the second-best year...

In most countries, antibiotics for oral administration are put on the market in fixed packages. When there is no exact unit dispensing of antimicrobials, drug pack size may influence prescribers’ choice of treatment duration. The aim of this st...

Antimitotic agents are one of the more successful types of anticancer drugs, but they suffer from toxicity and resistance. The application of approved drugs to new indications (i.e., drug repurposing) is a promising strategy for the development of ne...

Novel antimicrobial agents, approved for clinical use in past years, represent potential treatment options for various infections. In this review, we summarize the most important medical and microbiological features of three recently approved fluoroq...