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Objectionable Conditions at Chicago Cornea

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Complete Response Letter for Aldeyra ADX-2191

[ Price : $8.95]

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

[ Price : $8.95]

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

ChatGPT Companies Want Regulation: Califf

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FDA commissioner Robert Califf says the agency needs to get in front of regulating large language models using ChatGPT that could ...

Ways to Address GSI Shortages: Report

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Two Brookings Institution fellows suggest three steps to address the shortage of generic sterile injectable drugs.

Blincyto Get FDA Full Approval

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FDA grants full approval to Amgens previously accelerated-approved BLA for Blincyto (blinatumomab) for treating certain adults and...

FDA Cancer Biomarker Pilot

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FDA launches a pilot program to post laboratory-developed test performance information using biomarkers to help facilitate better ...

Complete Response on F2G Antifungal NDA

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FDA issues F2G Ltd. a complete response letter on its NDA for olorofim, an antifungal for invasive fungal infections in patients w...