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FDA accepts for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on main...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Jemperli (...[ 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 ...[ Price : $8.95]
Megadyne recalls and removes from the market all Mega Soft Pediatric Patient Return Electrodes after receiving reports of patient ...[ Price : $8.95]
FDA gives SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer.[ Price : $8.95]
Route 92 Medical recalls (Class 1) several lots of its products containing the Tenzing 7 Delivery Catheters due to multiple instan...[ Price : $8.95]
FDA grants Novartis a breakthrough therapy designation for Scemblix (asciminib) for treating adult patients with newly diagnosed P...[ Price : $8.95]
FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.