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No Safety Issues in Biosimilar Switches: CDER Research

[ Price : $8.95]

CDER researchers say their statistical analysis demonstrates that switching between biosimilars and their reference products is no...

ImmunoGen sBLA for Elahere Seeks Full Approval

[ Price : $8.95]

FDA accepts for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravta...

Pentagon Hits FDA on Generic Testing

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A lengthy Bloomberg News article outlines concerns the Defense Department, health systems, and Congress have about FDAs ability to...

Roche Positive Results with Breast Cancer Drug

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Roche says it will discuss with FDA and other health authorities positive results from the Phase 3 INAVO120 study of inavolisib in...

Device Tracking Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Device Tracking 21 CFR Pa...

FDA Releases Novartis Untitled Letter on GMPs

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An FDA untitled letter cautions Novartis that its manufacturing facility in Morris Plains, NJ, is deviating from current good manu...

ABK Biomedical Gets Breakthrough Status

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FDA grants ABK Biomedical a breakthrough device designation for its proposed Eye90 microspheres and its use in treating patients l...

Oncology Center Pact on Real-world Evidence

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FDAs Oncology Center of Excellence and real-world evidence company Syapse renew a four-year agreement to collaboratively develop a...

West Pharma Vial2Bag Admixture Device Cleared

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FDA clears a West Pharmaceutical Services 510(k) for its Vial2Bag Advanced 13mm admixture device.

FDA Puts Clinical Hold on Genentech MS Studies

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FDA issues a clinical hold on a Genentech multiple sclerosis clinical development program for fenebrutinib due to liver injury con...