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FDA OKs Jardiance/Synjardy for Pediatric Diabetes

[ Price : $8.95]

FDA approves Boehringer Ingelheims Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatment...

Reps Urge FDA Relief on Compounded Hormones

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Twenty-five bipartisan House representatives urge FDA to create patient-centered policies on compounded hormones that maintain pat...

Guide on LDTs Used With Cancer Drugs

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Federal Register notice: FDA makes available a final guidance entitled Oncology Drug Products Used with Certain In Vitro Diagnosti...

Former Tellus Researcher Diaz Debarred

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Federal Register notice: FDA permanently debars Daylen Diaz from providing services in any capacity to a person that has an approv...

Add Plant-Based Diet Notice to Some Agonists: Petition

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The Physicians Committee for Responsible Medicine asks FDA to require a notice on all glucagon-like peptide-1 receptor agonists th...

Objectionable Conditions at Chicago Cornea

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FDA warns Highland, IL-based Chicago Cornea Consultants about violations in its conduct of two clinical studies with investigation...

Bluebird Sickle Cell Gene Therapy BLA Accepted

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FDA accepts for priority review a bluebird bio BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for certain patients ...

AZ Halts Elarekibep Asthma Phase 2a Trial

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Pieris Pharmaceuticals says its partner AstraZeneca is discontinuing a Phase 2a study of the asthma drug elarekibep.

Complete Response Letter for Aldeyra ADX-2191

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An FDA complete response letter for Aldeyras ADX-2191 cites a lack of substantial evidence of effectiveness due to a lack of clini...

Anumana Gets Breakthrough on ECG-AI Algorithm

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FDA grants Anumana a breakthrough device designation for its ECG-AI algorithm for detecting cardiac amyloidosis.