Eligible women were ≥30 weeks pregnant at the time of informed consent. Since CRIB was a postmarketing study, all women enrolled were being treated with commercial CZP for a locally approved ...

6 The aim of the present study was to evaluate the effectiveness and tolerability of BRV in the postmarketing period to evaluate if the reduction in seizure frequency and adverse events reported in ...

In October 2024, the U.S. Food and Drug Administration (FDA) approved SELARSDI™ for all indications matching the reference ...

Allergan Aesthetics, an AbbVie company, today announced Allergan Medical Institute (AMI) will open three new state-of-the-art training centers in the U.S.

The terms immunized and vaccinated are often used interchangeably, but they have different meanings. Vaccination describes the act of receiving a vaccine. Immunization describes the process of ...

Lack of funding and hesitancy of industry to conduct clinical trials in SSA 2. Lack of access to standard-of-care cancer medications 1. Conduct phase IV postmarketing trials with already established ...

Drug safety relates to the potential for adverse effects related to the administration of drugs. Efforts to establish the safely profile of drugs begin early in their development, with in vitro ...

It goes on to say: "The FDA's periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical ...

PK studies include (1) early-phase studies including PK components, comprising (a) first-dose-in-child studies and (b) phase II and III studies; and (2) phase IV postmarketing PK studies (including, ...

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) ...