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Jemperlis Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Jemperli (...

Moderna RSV Vaccine Review Pushed Back

[ Price : $8.95]

FDA tells Moderna that it needs a couple more weeks to complete the review of its BLA for mRNA-1345, the companys investigational ...

Megadyne Removing Mega Soft Electrodes

[ Price : $8.95]

Megadyne recalls and removes from the market all Mega Soft Pediatric Patient Return Electrodes after receiving reports of patient ...

SN Bioscience Gets Fast Track for Lung Cancer

[ Price : $8.95]

FDA gives SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer.

Route 92 Medical Recalls Faulty Catheters

[ Price : $8.95]

Route 92 Medical recalls (Class 1) several lots of its products containing the Tenzing 7 Delivery Catheters due to multiple instan...

Breakthrough for Novartis Scemblix in Leukemia

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FDA grants Novartis a breakthrough therapy designation for Scemblix (asciminib) for treating adult patients with newly diagnosed P...

FDA Defines Device Remanufacturing

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FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.

FDA Leaders Financial Ties to Drug Industry Probed

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A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.

Exocel Bio Selling Unapproved Exosomes: FDA

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FDA says Exocel Bio in San Diego is marketing unapproved exosome products.

Vyaire Recalls Exercise Test Component

[ Price : $8.95]

Vyaire Medical recalls (Class 1) its Vyaire Twin Tube sample line 240 cm, Model Number V-707327, which is used in the companys Vyn...