The “plausible mechanism pathway” will allow personalised drugs to reach the market sooner for patients with genetic diseases ...

The decision aims to improve access to HRT by removing warnings about cardiovascular disease, breast cancer, and probable dementia. HHS has initiated removal of black box warnings on hormone ...

Poherdy is the first FDA-approved interchangeable biosimilar to Perjeta for HER2-positive breast cancer, potentially expanding access and reducing costs. Approved for use in combination with ...

The Food and Drug Administration’s recent approval of a second generic version of the abortion pill mifepristone has left people on both sides of the reproductive rights fight scrambling to ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid ...

The U.S. Food and Drug Administration is changing its policy on who should get COVID-19 shots, potentially limiting access to new vaccine formulations as they enter the market. New and updated jabs ...

Food and Drug Administration (FDA) Commissioner Marty Makary said he has no plans to change current policy to restrict access to the abortion pill mifepristone, despite a steady pressure campaign from ...

The other shoe has dropped for Roche’s bid to move Columvi into earlier treatment of diffuse large B-cell lymphoma (DLBCL) in the U.S. The FDA has declined to approve Columvi, in combination with the ...

The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and XGEVA® (denosumab): Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo ...

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct ...