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FDA Approves Amphastar Naloxone Nasal Spray

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FDA approves an Amphastar NDA for naloxone nasal spray for emergency treatment of an opioid overdose.

Shuren Addresses Firms Criticism as Misinformation

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CDRH director Jeff Shuren takes the unusual step of addressing a companys criticism directed at his Centers alleged delay in grant...

Animal Drug Regs Amended for Approval Actions

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Federal Register notice: FDA amends the animal drug regulations to include application-related actions for new animal drug applica...

FDA Updates EUA Listing for Medical Devices

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Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for certain medical devices intended for use d...

Mesoblast Remestemcel-L BLA Resubmitted

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FDA accepts a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host d...

Updated Safety Alert on Breast Implant Cancer

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An FDA safety update indicates that an agency literature review has found reports of 19 squamous cell carcinoma cases in the scar ...

FDA Revokes 2 Covid-19 Tests

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Federal Register notice: FDA revokes the Emergency Use Authorizations issued for two Covid-19 diagnostics Babson Diagnostics for ...

FDA Accepts BioMarin Voxzogo New Indication sBLA

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FDA will review a BioMarin sBLA to expand the approved achondroplasia treatment indication for Voxzogo to include children under a...

Covis Willing to Voluntarily Withdraw Makena

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Covis Pharma says it is willing to work with CDER on an orderly withdrawal of Makena from the market.

FDAs Cancer Patient-Focused Glossary

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Six Oncology Center of Excellence staff members describe the process used in developing a new patient-focused glossary of cancer c...