LEXINGTON, Mass. and AMSTERDAM, May 29, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, ...
It is well known within the biopharma industry that clinical studies can produce any number of unexpected and possibly disappointing outcomes, including false negative results, or in statistical ...
Representative clinical studies are important as diseases and medicines can affect people differently depending on their age, sex, and race and ethnicity. According to the Food and Drug Administration ...
Treace Medical Concepts, Inc. ('Treace” or the 'Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot ...
A key advantage of using RWD in a natural history study is gaining diverse and representative data. RWD covers broad patient populations, including those with comorbidities, various age groups, and ...
Xenon Pharmaceuticals provided an update on its pipeline programs, highlighting significant progress and upcoming milestones for 2025. The company anticipates topline data from its first Phase 3 study ...
Six months after its due date, the FDA’s draft guidance for clinical trial diversity is finally here. The agency on June 26 issued a new outline of its proposed requirements for the racial and ethnic ...
Clinical studies remain one of the most difficult phases in medical device development. They’re slow, expensive, and sometimes unpredictable — but completely necessary for nearly everything that ...
Industry sponsors will be required to submit diversity action plans for certain key clinical studies of drugs and devices, according to draft guidance released recently by the US Food and Drug ...
What Are Clinical Trials for MASH? Clinical trials for MASH are research studies that evaluate potential new treatments for a form of liver disease called metabolic dysfunction-associated ...
Diversity in clinical trials matters for drug safety and efficacy—and for future medical advancements. Clinical trial ...
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