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 ...
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 ...
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 ...
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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 ...
FDA seizes food samples worth ₹10.35 lakhs
The special campaign took place in the Pune region, which encompasses Pune, Solapur, Satara, Sangli, and Kolhapur districts ...
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 ...
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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 ...
FDA approves Anovo system for abdominal hernia repair
The U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance for the Anovo robotic surgery platform, developed by Momentis Surgical, for repairing ventral hernias. This approval adds to ...
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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 ...
Astellas Pharma's Cancer Drug Vyloy Gets FDA Approval
Astellas Pharma's drug Vyloy was approved for treatment of advanced gastric and gastroesophageal junction cancer by the Food and Drug Administration.