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FDA approves an Eli Lilly NDA for Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist for treating certa...[ Price : $8.95]
CBER posts 13 Form FDA-483s under the Freedom of Information Acts provision on frequently requested records.[ Price : $8.95]
FDA grants Biolinq a de novo authorization for its Shine system, said to be the first fully autonomous, needle-free glucose sensor...[ Price : $8.95]
FDA warns San Juan, Puerto Rico-based Cellebration LLC that it is violating the Federal Food, Drug, and Cosmetic Act and agency re...[ Price : $8.95]
Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for tre...[ Price : $8.95]
FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for se...[ Price : $8.95]
FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to...[ Price : $8.95]
Reps. Pfluger and Landsman introduce bipartisan legislation to deem biosimilars to be interchangeable upon FDA approval.