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265 Suicidal Reports on GLP-1 Drugs: Reuters

[ Price : $8.95]

According to Reuters, FDA says it is doing a thorough review of 265 reports of suicidal thoughts or behavior that may be associate...

Physiologic Closed-Loop Control Guidance

[ Price : $8.95]

FDA publishes a guidance on technical considerations for medical devices that use physiologic closed-loop control technology with ...

Graft-vs-Host Product Development Guidance

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FDA publishes a draft guidance to assist sponsors in developing various types of products to prevent or treat graft-versus-host di...

FDA Approves New Depression Drug

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FDA approves a Fabre-Kramer Pharmaceuticals NDA for Exxua (gepirone hydrochloride extended-release tablets) for treating major dep...

FDA OKs Pfizers Bosulif for Pediatric CML

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FDA approves a new indication for Pfizers Bosulif to treat some pediatric patients with chronic myelogenous leukemia.

Ileus Added to Ozempic Label Adverse Effects

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CBS News says FDA has approved a labeling change for Novo Nordisks Ozempic to acknowledge reports of ileus following use of the dr...

Gilead Ends AML Trial of Magrolimab

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Gilead says it ended the ENHANCE-2 trial of magrolimab in acute myeloid leukemia with TP53 mutations after determining it would no...

Prescription Information Modernization Bill

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Sens. Mullins and Booker introduce bipartisan legislation to permit electronic transmission of drug prescribing information to hea...

Eye Dilation Reversal Drops Approved

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FDA approves a Viatris and Ocuphire Pharma NDA for Ryzumvi (phentolamine ophthalmic solution) 0.75% for treating pharmacologically...

Boston Scientifics AVVIGO+ Guidance Device Cleared

[ Price : $8.95]

FDA clears a Boston Scientific 510(k) for its AVVIGO+ Multi-Modality Guidance System, which the company describes as a streamlined...