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Pfizers Besponsa Expanded Use in Pediatric Leukemia

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FDA approves Pfizers Besponsa (inotuzumab ozogamicin) for an expanded indication treating pediatric patients with relapsed or ref...

MIDD Pilot Lessons Learned

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CDER researchers describe lessons learned from the four-year Model-Informed Drug Development pilot program and plans for the progr...

Lantheus sNDA Approved for Definity Pediatric Use

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FDA approves a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid mi...

Quanterix Gets Breakthrough Status for Alzheimers Test

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FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 blood test as an aid in diagnostically evalua...

FDA Decision Denying Vanda sNDA Hearing

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Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER-proposed decision to not appro...

Info Collection Revision on NDA Form

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Federal Register notice: FDA sends to OMB an information collection revision entitled Applications for FDA Approval To Market a Ne...

Medfusion Syringe Pump Recalled Over Software

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Smiths Medical ASD recalls its Medfusion model 3500 syringe pump due to software-related issues that can cause the device to fail ...

sNDA for Ozempic Planned for Kidney Disease

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Novo Nordisk says it will file a supplemental NDA this year seeking an expanded label for Ozempic (semaglutide) for preventing pro...

FDA Approves Sandoz Prolia, Xgeva Biosimilars

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FDA approves Sandoz Jubbonti and Wyost, the first interchangeable biosimilars for Amgens Prolia and Xgeva.

Budget Compromise Gives FDA $160 Million Boost

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Senate and House appropriators post a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 millio...