Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer +4 more
wiley +1 more source
Novel Bridged Tricyclic Carbamoylpyridone Compounds as HIV Integrase Inhibitors for Treating HIV Infection. [PDF]
Sabnis RW.
europepmc +2 more sources
Pseudotumoral donovanosis mimicking squamous cell carcinoma in a patient with HIV infection. [PDF]
Carvalho BC +4 more
europepmc +1 more source
Precision medicine in paediatrics: Progress and priorities
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain +3 more
wiley +1 more source
Novel Heterocyclic Compounds for Treating HIV Infection. [PDF]
Sabnis RW.
europepmc +1 more source
Atypical Kaposi Sarcoma in HIV Infection with Predominant Nodal Involvement. [PDF]
Ruiz Barrera MD +6 more
europepmc +1 more source
Regulatory harmonization: Evolution, globalization and future directions
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm +2 more
wiley +1 more source
Hemophagocytic Lymphohistiocytosis as the Initial Presentation of Acute HIV Infection: A Case Report. [PDF]
Karrati S +4 more
europepmc +1 more source
Pharmacogenomics of dolutegravir: A scoping review of evidence, gaps and clinical implications
Dolutegravir underpins modern first‐ and second‐line HIV treatment regimens; however, interindividual variability in its disposition and tolerability presents challenges for optimal use. This scoping review mapped current evidence on the pharmacogenomics of dolutegravir, focusing on pharmacokinetics and pharmacodynamics, and methodological limitations ...
Ronald Kiguba +2 more
wiley +1 more source
AASLD practice guidance on drug, herbal, and dietary supplement–induced liver injury
Hepatology, EarlyView.
Robert J. Fontana +6 more
wiley +1 more source

