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 ...

HHS Secretary Robert F. Kennedy Jr. plans to axe members of the department’s vaccine-centric panels of outside advisers who he deems to be too cozy with the drug industry.

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 ...

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 ...

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 ...

Andrew Stanton is a Newsweek weekend reporter based in Maine. His role is reporting on U.S. politics and social issues. Andrew joined Newsweek in 2021 from The Boston Globe. He is a graduate of ...

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, ...