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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

[ Price : $8.95]

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, e...

FDA Delays Review Action on Alzheimers Drug

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FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation of Alzheimers drug Leqembi (l...

Legal Analysis Highlights Impact of FDA AI Clinical Trial Pilot

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A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinica...

Trump Denies Makary is on the Outs

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President Trump tells reporters he knows nothing about reports suggesting FDA commissioner Marty Makary will be asked to resign so...

Guide on Submitting Continuous Glucose Monitoring Data

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FDA posts new technical guidance document outlining how sponsors should submit continuous glucose monitoring data collected during...

Boston Scientific Device Correction on Certain Pacemakers

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Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy p...

White House Reportedly Moves to Oust Commissioner Makary

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Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.

Partner Therapeutics Wins Approval for Bile Duct Cancer Therapy

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FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cho...

Atara says FDA outlined potential path for Cell Therapy Resubmission

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Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path ...

Postapproval Pregnancy Safety Studies Guidance Available

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FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs...