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FDA, Vyloy and gastric
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.
FDA, Parkinson's disease
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 cholangitis.
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 study participants.
FDA Approves AbbVie's Parkinson's Disease Drug Vyalev
Thursday said that the U.S. Food and Drug Administration (FDA) has approved Vyalev for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). The approval was supported by the pivotal phase 3 study evaluating Vyalev in adults with advanced PD compared to carbidopa/levodopa,
10h
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 ...
9h
on MSN
Ex-FDA food expert reveals worst cereal in America with link to cancer
An ex-FDA employee has revealed what he claims is the most harmful breakfast cereal on the U.S. market.
1h
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 ...
12h
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 ...
BioSpace
10h
FDA Pushes Back PDUFA Dates for Amgen and Intercept
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic ...
20h
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, ...
Medscape
5h
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.
JD Supra
5h
Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell ...
8h
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 ...
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