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FDA Panel: All Thumbs Down for GLP-1 Agonist Implant for Diabetes

We haven't seen 'the best version of this device,' said panel member

University schoolUnited statesVanderbilt universityNew yorkPatrick nachmanRobert greevyBrendan everettJill crandallDavid cookeMarvin konstamUniversity of minnesotaTufts university school of medicineJohns hopkins university school of medicineUniversity of colorado hospital in auroraAlbert einstein college of medicineVanderbilt university medical center

FDA advisers discuss twice-rejected diabetes drug implant

FDA panel is gathering Sept. 21 to discuss ITCA 650, a Type 2 diabetes drug delivery product under review for possible approval. The experimental therapy has been denied approval twice.

United statesMetabolic drugs advisory committeeIntarcia therapeuticsTca 650Type 2 diabetesDrug deliveryIntarcia therapeuticsGlp 1

Third Time s a Charm for GLP-1 Diabetes Device? FDA Staff Suggest Otherwise

Advisory committee to weigh in on safety concerns with GLP-1 receptor agonist implant

New yorkUnited statesMetabolic drugs advisory committeeIntarcia therapeuticDrug evaluationNew york city

Health Care Week in Review: CMS Announces Details to Pay Drug Costs on Installment Plan | Alston & Bird

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and.

Heather dlugolenskiMichael chernewToyin ajayiBill kramerPeter neumannCori uccelloLewis sandyAmitabh chandraKatherine baickerMichael conwayVincent morJohn haupertPatricia mactaggartCraig garthwaiteDavid meltzerKosali simon

FDA grants approval to Ipsen for ultra-rare bone disease drug

Ipsen heralded the greenlight of the treatment, which reduces new, abnormal bone formation in soft and connective tissues for people living with FOP.

United statesHoward mayerEuropean commissionDrug administrationMetabolic drugs advisory committeeIpsen pharmaceuticalMetabolic drugs advisoryEuropean medicine agencyMedicinal productsHuman useAlbireo pharma

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