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The Association for Accessible Medicines calls on FDA to produce several guidances for generic oligonucleotide drugs.[ Price : $8.95]
FDA accepts for review an Eisai BLA for Leqembi (lecanemab-irmb) subcutaneous autoinjector weekly maintenance dosing for treating ...[ Price : $8.95]
FDA clears an Icotec 510(K) for the use of its BlackArmor carbon/PEEK implants for treating de novo spinal infections.[ Price : $8.95]
FDA awards Spear Bio a breakthrough device designation for its pTau 217 blood test for early diagnosis of Alzheimers disease.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled Generic Drug User Fee Program to allow ...[ Price : $8.95]
As he prepares to resign his post, FDA commissioner Robert Califf posts what is likely his final essay and personal reflection on ...[ Price : $8.95]
FDA accepts for priority review an AstraZeneca and Daiichi Sankyo BLA for datopotamab deruxtecan for treating certain adult patien...[ Price : $8.95]
Philips recalls its Monitoring Service Application concerning the Mobile Cardiac Telemetry Monitoring (BTPS-1000) system after ide...