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FDA Approves First Fecal Microbiota Product

The U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of...

Blueprint Medicines Submits Supplemental New Drug Application to FDA for AYVAKIT

Blueprint Medicines Corporation announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration (FDA) for AYVAKIT® (avapritinib) for...

FDA Advances the New Era of Smarter Food Safety, to Improve Traceability of Contaminated Foods

The U.S. Food and Drug Administration announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace...

Libtayo in Combination with Chemotherapy Approved by the FDA as First-line Treatment

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy...

FDA Approves Cochlear’s Nucleus 8 Sound Processor, Smaller, Smarter, Better Connected Cochlear Implant Technology

Cochlear Limited, the global leader in implantable hearing solutions, receives U.S. Food and Drug Administration (FDA) approval for the Cochlear™ Nucleus® 8 Sound Processor....
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