Explore the latest in drug development, including evolving methodologic, economic, and regulatory challenges to new drug innovation.
This Special Communication analyzes and compares development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment costs of biologics with small-molecule drugs.
This cohort study investigates the regulatory fate in the European Union for drugs that received accelerated approval for cancer indications in the US.
This longitudinal cross-sectional study compares how frequently reports of drug-related supply chain issues were associated with drug shortages in the US compared with Canada.
This Viewpoint discusses new pathways for researchers to seek collaboration when conducting studies on treatments for rare diseases and conditions.
This cross-sectional study examines the recommendations and agency actions of temporary and permanent US Food and Drug Administration advisory committee members from 2017 to 2021.
This randomized clinical trial investigates the effects of a traditional Chinese medicine formulation (Tongxinluo) compared with placebo on functional outcome in patients with acute ischemic stroke.
This cross-sectional study evaluates premarket end points in pivotal clinical trials supporting FDA breakthrough therapy鈥揹esignated approvals for original indications and postmarketing requirements for approvals based on confirmatory trials using surrogate markers as primary end points.
This randomized, adaptive phase 2 to 3 clinical trial assesses the efficacy and safety of HSK16149 capsules, an oral 纬-aminobutyric acid (GABA) analogue, to treat patients with diabetic peripheral neuropathic pain.
This Viewpoint analyzes the Psychopharmacologic Drugs Advisory Committee鈥檚 decisions regarding 3,4-methylenedioxymethamphetamine鈥揳ssisted therapy and what they mean for psychedelic research.
This randomized clinical trial evaluates the efficacy and safety of ZY5301 tablets for the treatment of chronic pelvic pain in women in China with pelvic inflammatory disease.
This cross-sectional study assesses the proportion of immunotherapy trials for breast cancer since 2004 that have failed to report their outcomes, the proportion of these trials that have yielded positive results, and the features associated with both outcomes.
This cross-sectional study examines changes in the use of and liver function test monitoring for ambrisentan and bosentan after changes by the US Food and Drug Administration to the ambrisentan labeling and risk evaluation and mitigation strategy.
This quality improvement study investigates the association of interruptions during psychedelic therapy with ratings of intensity of experience.
This meta-analysis of phase 1 trial data from a single institution assesses whether Asian, Hispanic, and non-Hispanic Black trial participants with advanced cancer experience similar response outcomes as non-Hispanic White trial participants.
This economic evaluation estimates the cost of drug development by therapeutic class and trends in pharmaceutical research and development intensity in the US from 2000 to 2018.
This Viewpoint discusses the recent US Supreme Court ruling allowing mifepristone鈥攁 drug used in medication abortion鈥攖o be widely available in the US, summarizes the history of challenges to the availability of mifepristone, and highlights reasons for concerns that remain after the Court鈥檚 current ruling.
This randomized clinical trial investigates whether administration of early, low-dose oral diazoxide in neonates with severe or recurrent hypoglycemia reduces time to normoglycemia.
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