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FDA Approves Impel NeuroPharmas Trudhesa

[ Price : $8.95]

FDA approves Impel NeuroPharmas Trudhesa migraine nasal spray treatment.

TransMedics OCS Heart System Approved

[ Price : $8.95]

FDA approves a TransMedics Group PMA for its OCS Heart System for use with organs from donors after brain death.

Notice on Pediatric Panel Meeting Corrected

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Federal Register notice: FDA corrects an 8/10 notice announcing a 9/17 Pediatric Advisory Committee meeting.

Device Reclassification Petition Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical...

Info Collection on Rx Drug Labeling

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled Labeling Requirements for Prescription ...

Pfizer Booster Vaccine Panel Meeting Details

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Federal Register notice: FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfi...

CDER Starts Novel Excipient Review Pilot Program

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CDER starts its Novel Excipient Review Pilot Program to foster the development of excipients for when excipient manufacturers and ...

Objectionable Conditions Found in Kaleido Inspection

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FDA warns Kaleido Biosciences that it conducted clinical trials on an investigational Covid-19 drug without submitting an IND.

FDA Clinical Hold on BioMarin Phearless Study

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FDA places a clinical hold on a BioMarin gene therapy study to treat adults with phenylketonuria.

FDA Accepts 2 Submissions for Sickle Cell Drug

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FDA accepts for priority review a Global Blood Therapeutics supplemental NDA and a separate NDA for Oxbryta (voxelotor) and its us...