Intercept’s liver disease drug Ocaliva faces FDA approval delay
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...
Food Safety News1h
FDA updates food import alerts for unapproved drugs, heavy metals and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.
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 ...
GlobalData on MSN6h
Avadel wins FDA approval for narcolepsy drug Lumryz in children
The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...
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 ...
Medscape9h
FDA OKs Zolbetuximab for Gastric, Gastroesophageal Cancer
FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. and Roche Diagnostics, to ...
Reher: Counterfeit weight-loss drug crisis looms
Bad actors are using online ads, social media and bootleg ingredients to sell fake, inaccurate and harmful versions of these ...
Nationwide Antidepressant Recall Update As FDA Sets Risk Class
On October 11, the recall was classified as a class II recall by the FDA—a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health ...
Ice Cream Recall Update As FDA Sets Risk Level Over Undeclared Ingredients
The U.S. Food and Drug Administration ( FDA) has classified the recall of a brand of ice cream as Class II after it was discovered that the product contained undeclared food colorings Yellow 5 ...
NetNewsLedger8h
Canadian Health Authorities Prohibit Common Food Additive Brominated Vegetable Oil: Key Details You Should Know
Health Canada has officially banned the use of brominated vegetable oil (BVO) as a food additive. The decision comes amid ...
Medscape10h
FDA OKs Novel Levodopa-Based Continuous Sub-Q Regimen for Parkinson’s
Vyalev (AbbVie) is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy to address motor fluctuations in advanced Parkinson’s disease.
Kansas, Missouri AGs renew push to restrict abortion drug after Supreme Court ruling
The complaint, filed against the FDA, comes after the U.S. Supreme Court ruled in June that a group of doctors couldn’t sue ...