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Federal Register notice: FDA determines that Fresenius Kabi USAs Naropin (ropivacaine HCl) solution was not withdrawn due to safet...[ Price : $8.95]
FDA publishes an immediately effective guidance removing an expiration for some enforcement policies for certain non-invasive remo...[ Price : $8.95]
FDA approves a UCB BLA for Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe plaque psoriasis in adults who are candidate...[ Price : $8.95]
FDA clears an Intellia Therapeutics IND to permit a Phase 3 trial of its NTLA-2001 to treat transthyretin amyloidosis with cardiom...[ Price : $8.95]
FDA clears a GE HealthCare 510(k) for its Allia IGS Pulse imaging system.[ Price : $8.95]
FDA clears a Praxis Medical 510(k) for its EndoCore EBUS-TBNA fine needle biopsy device.[ Price : $8.95]
After 15 years at FDA, former senior regulatory counsel Joy Sharp joins the law firm Faegre Drinker as counsel in Washington, DC.[ Price : $8.95]
FDA approves Mercks Keytruda (pembrolizumab) for use with platinum-containing chemotherapy as neoadjuvant treatment and continuing...