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Comparing timelines and evidence available to support new TB, HIV, and HCV drug approvals: The same, only different.

BACKGROUND: Tuberculosis (TB), human immunodeficiency virus (HIV), and hepatitis C virus (HCV) share a global presence and propensity to dis … nt arms containing the drug; and the total number of participants in each trial from the individual drug approval packages. We found that the two TB drugs took longer to gain approval (8.0 and 19.2 years for bedaquiline and pretomanid, respectively) despite availing of special regulatory pathways meant to expedite approval, when compared to the HIV (2.6 years f …

Repurposing of FDA-approved drugs as inhibitors of sterol C-24 methyltransferase of Leishmania donovani to fight against leishmaniasis.

Leishmaniasis is a vector-borne disease caused by around 20 species of Leishmania. The main clinical forms of leishmaniasis are cutaneous leishmaniasis (CL) and visceral leishmaniasis (VL). VL is caused by Leishmania infantum in Central and South America, Mediterranean Basin, Middle East, and by L. donovani in Asia and Africa. Sterol C-24 methyltransferase (LdSMT) of L. donovani is a transferase enzyme of the sterol biosynthesis pathway. This pathway is one of the major targets for drug developments in Leishmania. Due to insufficient evidence about the exact function of SMT inside the cell and

New pharmaceuticals approved by FDA in 2020: Small-molecule drugs derived from amino acids and related compounds.

Amino acids (AAs) play an important role in the modern health industry as key synthetic precursors for pharmaceuticals, biomaterials, biosensors, and drug delivery systems. Currently, over 30% of small-molecule drugs contain residues of tailor-made AAs or derived from them amino-alcohols and di-amines. In this review article, we profile 12 AA-derived new pharmaceuticals approved by the FDA in 2020. These newly introduced drugs include Tazverik (epithelioid sarcoma), Gemtesa (overactive bladder), Zeposia (multiple sclerosis), Byfavo (induction and maintenance of procedural sedation), Cu 64 dota

Remdesivir and Ledipasvir among the FDA-Approved Antiviral Drugs Have Potential to Inhibit SARS-CoV-2 Replication.

The rapid spread of the virus, the surge in the number of deaths, and the unavailability of specific SARS-CoV-2 drugs thus far necessitate the identification of drugs with anti-COVID-19 activity. SARS-CoV-2 enters the host cell and assembles a multisubunit RNA-dependent RNA polymerase (RdRp) complex of viral nonstructural proteins that plays a substantial role in the transcription and replication of the viral genome. Therefore, RdRp is among the most suitable targets in RNA viruses. Our aim was to investigate the FDA approved antiviral drugs having potential to inhibit the viral replication. T

In silico screening of potent inhibitors against COVID-19 key targets from a library of FDA-approved drugs.

Coronavirus disease (COVID-19) is an emerging pandemic that threatens the world since the early days of 2020. Development of vaccines or new drugs against COVID-19 comprises several stages of investigation including efficacy, safety, and approval studies. A shortcut to this delicate pathway is computational-based analysis of FDA-approved drugs against assigned molecular targets of the coronavirus. In this study, we virtually screened a library of FDA-approved drugs prescribed for different therapeutic purposes against versatile COVID-19 specific proteins which are crucial for the virus life cy

Evaluation of a Library of FDA-Approved Drugs for Their Ability To Potentiate Antibiotics against Multidrug-Resistant Gram-Negative Pathogens.

The Prestwick library was screened for antibacterial activity or "antibiotic resistance breaker" (ARB) potential against four species of Gram-negative pathogens. Discounting known antibacterials, the screen identified very few ARB hits, which were strain/drug specific. These ARB hits included antimetabolites (zidovudine, floxuridine, didanosine, and gemcitabine), anthracyclines (daunorubicin, mitoxantrone, and epirubicin), and psychoactive drugs (gabapentin, fluspirilene, and oxethazaine). These findings suggest that there are few approved drugs that could be directly repositioned as adjunct a

[Ten years experience with the first approved biosimilar recombinant human growth hormone drug in normal clinical practice].

INTRODUCTION: Recombinant human growth hormone (rhGH) is the first biosimilar drug approved by the European Medicines Agency in 2006, using the biosimilar registration process. It was authorised for the treatment of growth hormone deficiency, and growth disorders associated with Turner's syndrome, chronic renal failure, Prader-Willi syndrome, and growth disorders in children/adolescents born small for gestational age, and replacement therapy in adults with pronounced growth hormone deficiency. MATERIALS AND METHODS: This review is focused on the scientific evidence published about this drug i

Screening of a Library of FDA-Approved Drugs Identifies Several Enterovirus Replication Inhibitors That Target Viral Protein 2C.

Enteroviruses (EVs) represent many important pathogens of humans. Unfortunately, no antiviral compounds currently exist to treat infections with these viruses. We screened the Prestwick Chemical Library, a library of approved drugs, for inhibitors of coxsackievirus B3, identified pirlindole as a potent novel inhibitor, and confirmed the inhibitory action of dibucaine, zuclopenthixol, fluoxetine, and formoterol. Upon testing of viruses of several EV species, we found that dibucaine and pirlindole inhibited EV-B and EV-D and that dibucaine also inhibited EV-A, but none of them inhibited EV-C or

Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study.

This study investigated postmarketing safety events (PMSEs) for new drugs approved in Brazil and evaluated whether a range of drug characteristics influenced the time between approval and the first PMSE. This retrospective study included new drugs registered between 2003 and 2013 by the National Health Surveillance Agency (ANVISA), which is responsible for medicines approval in Brazil. PMSEs were defined as any drug safety alert or drug withdrawal from the market. The existence of risk evaluation and mitigation strategies (REMS) by the US Food and Drug Administration (FDA) and Brazil were reco

Barriers in the quest for quality drug information: salutary lessons from TGA-approved sources for thyroid-related medications.

Product information (PI) for thyroid-related medications endorsed by the Therapeutic Goods Administration, as reproduced in the commonly used compilation publications June 2006 MIMS (Monthly index of medical specialties) annual, MIMS Online and the Australian prescription products guide 2006, was evaluated to see whether it reflects contemporary therapeutic practice. Compared with current medical literature, these PI-based sources provide inadequate, inaccurate or outdated therapeutic directives. Examples include: Incorrect advice that thyroxine therapy should always begin at very low dosage.

Artificial intelligence enabled parabolic response surface platform identifies ultra-rapid near-universal TB drug treatment regimens comprising approved drugs.

BACKGROUND: Shorter, more effective treatments for tuberculosis (TB) are urgently needed. While many TB drugs are available, identification of the best regimens is challenging because of the large number of possible drug-dose combinations. We have found consistently that responses of cells or whole animals to drug-dose stimulations fit a parabolic response surface (PRS), allowing us to identify and optimize the best drug combinations by testing only a small fraction of the total search space. Previously, we used PRS methodology to identify three regimens (PRS Regimens I-III) that in murine mod

International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway.

BACKGROUND: The US Food and Drug Administration (FDA) can grant earlier access to promising therapies through its accelerated approval pathway, conditional on post-authorisation trials confirming clinical benefit. Between 1 January 2010 and 31 December 2024, the FDA granted accelerated approval to 59 haematological malignancy drug indications, 13 of which were subsequently withdrawn because of unconfirmed clinical benefit or safety concerns. METHODS: We assessed the regulatory status and reimbursement recommendations for these 13 FDA-withdrawn drug indications in Australia, Canada, and Englan

Pulsed Field Ablation for Cardiac Arrhythmias: Industry Landscape and US Food and Drug Administration-approved Platforms (2025).

Pulsed field ablation (PFA) has rapidly advanced from an experimental modality to a front-line therapy for catheter ablation of atrial fibrillation (AF). Unlike thermal approaches such as radiofrequency (RF) or cryoablation, PFA relies on irreversible electroporation, producing rapid and selective myocardial lesions with minimal risk of collateral injury. This review examines the contemporary landscape of PFA technology, with emphasis on recent United States Food and Drug Administration (FDA) approvals that have expanded PFA from single-energy, single-shot systems toward focal and hybrid ablat

Integrated computational screening of FDA-approved anticancer drugs as novel HPV-16 E6 inhibitors in cervical cancer.

Cervical cancer, predominantly induced by high-risk human papillomavirus (HPV) strains, remains a significant global health burden despite advancements in cancer therapeutics. Among viral oncoproteins, the HPV-16 E6 protein plays a pivotal role in carcinogenesis by targeting tumor suppressor pathways, making it an attractive therapeutic target. This study introduces an integrated computational framework for systematically repurposing FDA-approved anticancer drugs as potential E6 inhibitors. A library of 100 anticancer drugs was screened using machine learning models, with Gradient Boosting ach

Regulatory approval, reimbursement and postmarketing evidence of class 1 novel drugs in China, 2018-2023: an observational study.

INTRODUCTION: The global pharmaceutical industry is undergoing profound changes, with countries worldwide actively investing in innovation ecosystems. In China, innovation has been incentivised through policies aimed at regulatory modernisation, value-based reimbursement and health system integration. In particular, expedited regulatory pathways and inclusion of innovative drugs into the National Reimbursement Drug List (NRDL) through value-based pricing were key approaches adopted by Chinese health authorities. To describe developments under these policies, we map the regulatory approval, rei

Patient-reported outcomes in clinical trials leading to breast cancer drug approvals: are we making them count?

PURPOSE: Patient-reported outcomes (PROs) inform benefit-risk tradeoffs in breast cancer treatment, yet reporting quality across registration trials remains incompletely characterized. METHODS: We conducted a scoping review of PRO reporting in randomized trials supporting FDA breast cancer drug approvals (January 2011-December 2024), identified via the FDA Oncology Approval Notifications database. Associated manuscripts were retrieved through systematic PubMed and EBSCO searches using trial-specific NCT identifiers. We assessed PRO endpoint prespecification status, instruments used, PRO publi…

Drug Repurposing for AML: Structure-Based Virtual Screening and Molecular Simulations of FDA-Approved Compounds with Polypharmacological Potential.

Background: Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy characterized by impaired differentiation, apoptosis resistance, and metabolic reprogramming, which collectively contribute to therapeutic resistance and poor clinical outcomes. While targeted agents-such as LSD1 inhibitors, the BCL-2 inhibitor venetoclax, and IDH1 inhibitors-have provided clinical benefit, their efficacy is often limited by compensatory signaling and clonal evolution. This study aimed to identify FDA-approved compounds with multitarget potential to simultaneously modulate key epigenetic, apopto

Animal Models in Regulatory Breakpoint Determination: Review of New Drug Applications of Approved Antibiotics from 2014-2022.

We sought to better understand the utility and role of animal models of infection for Food and Drug Administration (FDA)-approved antibiotics for the indications of community-, hospital-acquired-, and ventilator-associated bacterial pneumonia (CABP, HABP, VABP), complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI), and acute bacterial skin and structural infections (ABSSSIs). We reviewed relevant documents from new drug applications (NDA) of FDA-approved antibiotics from 2014-2019 for the above indications. Murine neutropenic thigh infection models supported

Improvements in the health-related quality-of-life benefit of cancer drugs approved in China, 2005-2020: an observational study.

BackgroundHealth-related quality of life (HRQoL), along with overall survival (OS), is a critical study endpoint for measuring the clinical benefits of cancer drugs. Previous studies have examined the OS benefit of new cancer drugs approved in China. However, their HRQoL benefits have not been systematically evaluated. We aimed to characterise the measurement and improvement of HRQoL associated with cancer drugs approved in China.MethodsThis mixed-methods study comprises of a literature review and a cross-sectional study, including all antineoplastic agents approved in China between January 1,

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… However, many cancer drugs approved by regulatory agencies in the US and Europe lack evidence of HRQoL improvement. … Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. BMJ. 2017;359 doi: 10.1136/bmj.j4530. …