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AI Optics Handheld Retinal Imager Cleared

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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 ...

Stroke Device Cleared for Larger Catheters

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FDA clears an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters.

Supernus Wins Label Update for ADHD Drug

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FDA approves a Supernus Pharmaceuticals label update for attention-deficit/hyperactivity disorder drug Qelbree (viloxazine extende...

Provepharm Recalls Phenylephrine HCl

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Provepharm recalls one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL due to a customer complaint about visible black...

Once Monthly Leqembi for Alzheimers Approved

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FDA approves an Eisai/Biogen supplemental BLA for Leqembi (lecanemab-irmb) and its intravenous use once every four weeks as mainte...

Pfizer Pays $60 million to Settle Biohaven Kickbacks

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Pfizer agrees to pay $59.7 million to resolve allegations that its subsidiary, Biohaven Pharmaceutical, engaged in previous illega...