Clinical Trials Arena on MSN

FDA unveils new pathway to usher bespoke therapies to market

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

FDA approves Poherdy, first biosimilar of Perjeta, to treat HER-positive breast cancer

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 ...
Opinion
Yakima HeraldOpinion

Column: The FDA’s mifepristone decision has baffled both sides

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 ...
FiercePharma

FDA rejects Roche's Columvi in earlier diffuse large B-cell lymphoma, citing lackluster US data

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 ...
CBS News

Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials

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 ...
Los Angeles Times

Letters to the Editor: What makes drug research so expensive, even before the FDA approval process?

This is read by an automated voice. Please report any issues or inconsistencies here. A rare-disease patient questions what drives research costs behind $41,000-per-month medication, even before FDA ...