Posts filtered by tags: Fda[x]


Juul's Latest Idea to Placate the FDA Is a Massive Vape-Tracking Program

As the U.S. Food and Drug Administration continues to blast e-cigarette manufacturers—and Juul in particular—for a steep spike in youth vaping, the company has in recent months launched a number of initiatives to keep its products out of the hands of minors.Read more...
Tags: Science, Smoking, Fda, Tracking, Vaping, Juul, U S Food and Drug Administration, Massive Vape Tracking Program

Johnson & Johnson wins U.S. FDA approval for bladder cancer drug

Johnson & Johnson's drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced on Friday. The list price of the drug, known chemically as erdafitinib, will range between $10,080 to $22,680 for a 28-day supply, depending of the dose, J&J said. Balversa is the first approved drug in a class known as FGFR inhibitors that targets growth factor receptors involved in cell growth and division.
Tags: Science, Food And Drug Administration, Fda, Johnson, Johnson Johnson, J J, Balversa

U.S. FDA approves Johnson & Johnson's bladder cancer drug

The U.S. Food and Drug Administration on Friday approved Johnson & Johnson's treatment for patients with a form of bladder cancer. The green signal to the drug, Balversa, makes it the first approved treatment for bladder cancer that targets a genetic alteration known as FGFR3 or FGFR2, the FDA said. The approval was based on a clinical trial in 87 patients whose cancer had progressed after chemotherapy.
Tags: Science, Fda, Johnson, U S Food and Drug Administration, Johnson Johnson, Balversa

Pharma Stock Roundup: AZN, MRK, GSK Get Regulatory Approvals, Sandoz Inks New Deal

Glaxo (GSK) gets FDA approval for a new HIV medicine, Dovato. AstraZeneca (AZN)/Merck's (MRK) Lynparza gets approval in EU for metastatic breast cancer.
Tags: Science, Merck, Eu, Fda, Lynparza, Glaxo GSK, AZN MRK GSK

Merck's Keytruda Gets FDA Nod for Expanded Lung Cancer Group

Merck (MRK) gets FDA approval to include overall survival data from the KEYNOTE-042 study on Keytruda's label.
Tags: Science, Merck, Fda, Merck MRK

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