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FDA Accepts BLA for Alvotechs Simponi BLA

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FDA accepts for review an Alvotech and Teva Pharmaceuticals BLA for AVT05, a proposed biosimilar to Janssen Biotechs Simponi and S...

Enhertu Approval Broadens Breast Cancer Use

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FDA approves AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or met...

No Informed Consent at Trial Site: FDA

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FDA warns the Miami Dade Medical Research Institute and Dr. Americo Padilla about failing to obtain proper informed consent for pe...

2 Firms Illegally Selling Biologics: FDA

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FDA warns New York, NY-based Evolutionary Biologics and Chatsworth, CA-based Chara Biologics about illegally manufacturing and dis...

FDA Priority Review for New Merck Welireg Indication

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FDA sets 5/25 for its decision on a new indication for Mercks Welireg to treat patients with advanced pheochromocytoma and paragan...

AI Optics Handheld Retinal Imager Cleared

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FDA clears an AI Optics 510(k) for its Sentinel Camera, a handheld retinal imaging device for capturing images of the human eye.

TerSera Wants Prialt ANDA Conditions

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TerSera petitions FDA to require any ANDA referencing Prialt to conduct compatibility testing with the Medtronic pump that is spec...

RFK Jr.s Cousin Trashes Him on Eve of Hearing

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Robert F. Kennedy Jr.s cousin, Caroline Kennedy, sends a scathing letter about his background to U.S. senators on the eve of a con...

Additional Ozempic Indication Approved

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FDA approves a new indication for Novo Nordisks Ozempic to reduce the risk of worsening kidney disease and cardiovascular death in...

Alzheimers Assay Gets Breakthrough Designation

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FDA grants Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ...