pharmaphorum1h
FDA clears Astellas' Vyloy as first claudin 18.2 cancer drug
Vyloy is the first CLDN18.2-targeting drug to reach the US market but has already been approved in Japan as well as in the EU ...
FDA asks Texas court to shut down COVID-19 vaccine records lawsuit
The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to ...
Nationwide Antidepressant Recall Update As FDA Sets Risk Class
The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 ...
Food Safety News4h
FDA warns foreign seafood importers about serious HACCP violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The FDA on Thursday approved an injectable drug that eased Parkinson's disease symptoms and improved motor fluctuations in ...
FiercePharma2d
Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy
After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer ...
Commentary: FDA’s lack of vape enforcement is hurting small businesses
Thanks to the leadership of Gov. Ron DeSantis, Attorney General Ashley Moody and the Florida Legislature, a new state law to ...
STAT3d
The biggest challenge facing the FDA’s new Rare Disease Innovation Hub
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting ...
McKnight's Long-Term Care News1d
A new treatment option gets FDA approval for adults with advanced Parkinson’s disease
The US Food and Drug Administration has approved VYALEV, a groundbreaking therapy developed by AbbVie to treat adults with ...
Managed Healthcare Executive2d
FDA Approves First-in-Class Drug for Gastric Cancer
Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and ...
Listeria contamination prompts recall of generic waffle brands at retailers across U.S., FDA says
Generic waffle brands at retailers across the U.S. are being recalled after listeria, a potentially fatal bacterial disease, ...