The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an ...

Topline phase 3 OPUS-1 data show VAX-31 met coprimary immunogenicity endpoints, demonstrating noninferiority and superiority for key pneumococcal serotypes.

The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new drugs in clinical trials. The proposal aims ...

Eli Lilly has presented detailed results from the Phase III ACHIEVE-4 trial showing its oral GLP-1 receptor agonist Foundayo ...

Please provide your email address to receive an email when new articles are posted on . Noninferiority trials test whether a new treatment is not less efficacious than an already approved therapy.

Vaxcyte’s vaccine was pitted against standard-of-care jabs and proved non-inferior on nearly all serotypes.

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