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.
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 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.
US FDA expands approval for Avadel's sleep disorder drug
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for widely used treatments from Jazz Pharma.
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.
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 ...
GlobalData on MSN1d
FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment
The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor ...
CorMedix: Delayed Approval, Low Cash, Good Prospects
Read more on CorMedix (CRMD)'s FDA-approved DefenCath and its potential in the CRBSI market, but be cautious of stock spikes ...
WebMD13h
FDA Approves New Treatment for Advanced Parkinson’s Disease
The FDA has just approved a new injectable treatment for adults with advanced Parkinson’s disease called Vyalev (also known as Produodopa).
FDA Approves AbbVie's Parkinson's Treatment, Medicare Coverage Expected Next Year
Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor ...
Becker's Hospital Review19h
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 ...
medtechdive14h
Novocure wins FDA approval for electric field device in lung cancer
Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.
‘It’s very empowering’: Northeastern student on first FDA-approved OTC birth control
Brooke, a Northeastern University student, shares what it means to take Opill, the first FDA-approved over-the-counter birth ...
BioSpace19h
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 ...