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Biologics

Inovio Begins Rolling BLA for Rare Throat Disorder

Inovio Pharmaceuticals begins a rolling BLA submission for INO-3107, an experimental DNA medicine for recurrent respiratory papillomatosis.

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Human Drugs

Regeneron to Seek FDA OK for Myasthenia Gravis Drug

Regeneron Pharmaceuticals releases favorable Phase 3 data for its RNA-based therapy cemdisiran and says it will seek FDA approval early next year for ...

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Human Drugs

Lilly Plans NDA for Obesity Pill; Positive Data Released

Eli Lilly plans to seek approval for its investigational obesity pill orforglipron following positive topline results from the Phase 3 ATTAIN-2 trial....

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Medical Devices

QS Violations at LeMaitre Vascular

FDA warns North Brunswick, NJ-based LeMaitre Vascular about Quality System Regulation and other violations in its manufacturing of vascular grafts.

Human Drugs

Allaritys Stenoparib on FDA Fast Track

FDA grants fast track designation to Allarity Therapeutics investigational ovarian cancer drug stenoparib.

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Biologics

Axogen Nerve Graft Review Extended by 3 Months

FDA extends by three months its review of an Axogen BLA for Avance Nerve Graft after the agency determined that information submitted by the company i...

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Medical Devices

Breakthrough Status for Quests Haystack MRD Test

FDA grants Quest Diagnostics a breakthrough device designation for its Haystack MRD test, a liquid biopsy designed to detect minimal residual disease ...

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Medical Devices

Alert on Hyperbaric Oxygen Devices

FDA alerts health care providers and facilities about the safe use of hyperbaric oxygen therapy devices following reports of serious injuries and deat...

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Human Drugs

FDA Broadens Use of Amgens Repatha

FDA expands the approved use of Amgens cholesterol-lowering drug Repatha (evolocumab) to include adults at increased risk of major adverse cardiovascu...

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Biologics

Argenx Plans sBLA for Vyvgart in Myasthenia Gravis

Argenx says it will seek expanded approval for Vyvgart (efgartigimod alfa-fcab) to include adults with acetylcholine receptor antibody seronegative ge...