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FDA, Astellas
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 website showed on Friday.
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 med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.
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 gastroesophageal cancers.
Astellas Pharma's VYLOY Receives FDA Approval For Treatment Of Advanced Gastric And GEJ Cancer
Astellas Pharma Inc. (ALPMY, ALPMY) said that the U.S. Food and Drug Administration has approved VYLOY (zolbetuximab-clzb) in
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. The pharmaceutical company said Friday the FDA approved the drug for use in combination with fluoropyrimidine-and-platinum-containing chemotherapy.
19h
on MSN
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 ...
17h
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 ...
Benefits Pro
19h
Can the FDA just use 'march-in rights' to make its own Wegovy?
The "takings clause" in the Fifth Amendment to the U.S. Constitution might keep the federal government from creating ...
22h
on MSN
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 ...
Food Safety News
6h
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.
Targeted Oncology
15h
FDA Pushes Back Decision on Sotorasib/Panitumumab in Colorectal Cancer
The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal ...
1d
on MSN
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 ...
1d
on MSN
Her breast density camouflaged her cancer. She says new FDA regulations are "a gift."
"If I have dense breast tissue, am I more prone to get cancer?" CBS News New York's Kristine Johnson asked. "The answer is, ...
Becker's Hospital Review
19h
FDA approves first heart stent designed for infants, young children
The
FDA
has approved the Minima stent system, the first device specifically designed for infants and young children with congenital heart defects. The innovative stent could help thousands of ...
11h
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 ...
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