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Human Drugs

FDA Acting Against Unapproved Thyroid Meds

FDA says it will allow up to 12 months for doctors to transition patients who are taking unapproved animal-derived thyroid medications to approved syn...

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Human Drugs

Lilly Plans NDA for Oral Weight-Loss Drug

Eli Lilly says it will file an NDA by the end of the year for its investigational obesity treatment orforglipron, based on just-announced Phase 3 data...

Medical Devices

Alert on Boston Scientific Defibrillation Leads

FDA issues an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads that may impact shock e...

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Medical Devices

FDA Early Alert on Watchman Devices

FDA issues an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use instructions to preve...

Medical Devices

Quarantine Some Medline ReNewal Catheters

An FDA Early Alert says Medline ReNewal recommends that some reprocessed St. Jude electrophysiology catheters be quarantined due to the possibility th...

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Human Drugs

FDA Accelerated Approval for Jazz Modeyso

FDA grants accelerated approval for Jazz Modeyso to treat diffuse midline glioma.

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Medical Devices

QS, MDR Issues at Taiwans Visgeneer

FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood glucose and blood uric a...

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Medical Devices

Medical Device PFAS Appear Safe: FDA

FDA issues an online post describing the safety to patients of the type of PFAS used in medical devices.

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Medical Devices

BMS Files Breyanzi Marginal Zone Lymphoma sBLA

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for...

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Human Drugs

Lantheus NDA for Pylarify New Formulation

FDA accepts a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen imaging agent.