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FDA approves a Shire BLA for Takhzyro (lanadelumab-flyo) injection for preventing hereditary angioedema attacks in patients 12 yea...[ Price : $8.95]
FDA approves Janssen Biotech and Pharmacyclics Imbruvica (ibrutinib) in combination with Genentechs rituximab for treating Waldens...[ Price : $8.95]
CathWorks files a 510(k) for its CathWorks FFRangio System, a fractional flow reserve device that is intended to deliver objective...[ Price : $8.95]
FDA 8/24 sends a Warning Letter to a Zimmer Biomet subsidiarys manufacturing facility in Warsaw, IN over GMP issues documented in ...[ Price : $8.95]
Pfizer petitions FDA to issue a guidance document to clarify appropriate sponsor communications about the nature and properties of...[ Price : $8.95]
Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learni...[ Price : $8.95]
Federal Register notice: FDA determines that Plasma Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancy and Oncologic Disease: Consideration...