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Cabaletta Bio Gains Fast Track on CABA-201

[ Price : $8.95]

FDA grants Cabaletta Bio a fast track designation for CABA-201, an investigational 4-1BB-containing CD19-CAR T cell therapy.

Endotronic Files PMA for Home Heart Monitor

[ Price : $8.95]

Endotronix files a PMA for the Cordella Pulmonary Artery (PA) Sensor System, a heart failure patient management platform for home ...

Omnipod 5 Insulin Pump Calculator Recalled

[ Price : $8.95]

Insulet Corp. recalls its Omnipod 5 smartphone application and software that is used to control an insulin pump due to an error in...

FDA Approves Florida Drug Importation

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FDA authorizes Floridas importation program that will allow drugs to be imported from Canada as long as certain conditions are met...

Nanowear Wearable Diagnostic Cleared

[ Price : $8.95]

FDA clears a Nanowear 510(k) for the companys SimpleSense, a nanotechnology-enabled wearable and software platform.

Novartis Radioligand Manufacturing Site Approved

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FDA approves Novartis Radioligand Therapy manufacturing facility in Indianapolis, IN, to produce prostate cancer therapy Pluvicto....

Vaccine Hesitancy Threatening Public Health: FDA

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FDA leaders say anti-vaxxers and those that are vaccine-hesitant due to safety concerns or religious beliefs are threatening U.S. ...

ModernaTX Hit with 483 Over GMPs

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FDA issues ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection documented GMP violations.

Rep. Murphy Wants FDA Artificial Intelligence Info

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Rep. Gregory Murphy asks FDA for its views on several aspects of using artificial intelligence in medical care as a prelude to reg...