Page 33 - Risk Evaluation News Today

With these results, Breyanzi has now demonstrated clinically meaningful benefit across the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy, underscoring the... | May 1, 2023

The FDA has granted final approval to Lumryz, a once-nightly sodium oxybate for the treatment of cataplexy or EDS in adults with narcolepsy. 

The legal profession and medical profession have distinct universes with rules and standards that operate well and efficiently in their respective environments.

Texas Dist Court stayed FDA 23 year approval Mifeprex or Mifepristone Fifth Circuit to hear appeal injunction oral arguments appellate court. Depending on appellate case could go Supreme Court for final determination.

During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug...

This Viewpoint discusses recent US court decisions on the availability of mifepristone, a drug used to terminate pregnancies, and how these conflicting court de

If approved, CAMZYOS would be the first cardiac myosin inhibitor in Europe that specifically targets the source of obstructive HCM Recommendation based on positive Phase 3 EXPLORER-HCM and... | June 18, 2023

As the legal battle over the U.S. Food & Drug Administration's approval of the abortion pill mifepristone continues, a new citizen's petition demands that access to the drug be prohibited until the FDA can determine the threat it poses to the environment. 

As the legal battle over the U.S. Food & Drug Administration's approval of the abortion pill mifepristone continues, a new citizen's petition demands that access to the drug be prohibited until the FDA can determine the threat it poses to the environment. 

Daiichi Sankyo announced that the new deadline for review of the application is July 24, 2023.