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Regeneron to Seek FDA OK for Myasthenia Gravis Drug

[ Price : $8.95]

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

Lilly Plans NDA for Obesity Pill; Positive Data Released

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Eli Lilly plans to seek approval for its investigational obesity pill orforglipron following positive topline results from the Pha...

QS Violations at LeMaitre Vascular

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

Allaritys Stenoparib on FDA Fast Track

[ Price : $8.95]

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

Axogen Nerve Graft Review Extended by 3 Months

[ Price : $8.95]

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

Breakthrough Status for Quests Haystack MRD Test

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

Alert on Hyperbaric Oxygen Devices

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

FDA Broadens Use of Amgens Repatha

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

Argenx Plans sBLA for Vyvgart in Myasthenia Gravis

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

Chikungunya Vaccine Suspended Due to Safety Concerns

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CBER suspends Valneva Austrias BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine.