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FDA, Astellas Pharma and VYLOY
FDA approves Astellas’ VYLOY for gastric cancer treatment
Astellas Pharma has received approval from the FDA for VYLOY in conjunction with chemotherapy, for the treatment of advanced gastric cancer.
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 and GB. Astellas refiled its marketing application in May and the FDA gave it a six-month priority review, reflecting its status as the first drug targeting a brand-new oncology target.
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.
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.
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on MSN
Amid backlash, FDA changes course over shortage of weight-loss drugs
The FDA said Eli Lilly’s weight-loss drugs were no longer in shortage on Oct. 2, preventing pharmacies from making cheaper ...
2d
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 ...
2d
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 ...
Food Safety News
4h
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 ...
3d
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 ...
Opinion
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Opinion
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 ...
STAT
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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 News
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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 ...
14h
on MSN
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, ...
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