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EUA for CDC Monkeypox Diagnostic

[ Price : $8.95]

Federal Register notice: FDA grants an Emergency Use Authorization to the U.S. Centers for Disease Control and Prevention for its ...

EUA for Monkeypox Home Collection Kit

[ Price : $8.95]

FDA grants Laboratory Corp. of America an Emergency Use Authorization for the Labcorp Monkeypox PCR Test Home Collection Kit.

Info Collection on Device Reclassification Petitions

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical...

Philips Recalls Sense XL Torso MRI Coils

[ Price : $8.95]

Philips North America recalls its Sense XL Torso (1.5T and 3.0T) MRI coils to update use instructions due to a potential issue whe...

Groups Want Changes in Drug Labeling Guidance

[ Price : $8.95]

Two drug company associations recommend changes to an FDA draft guidance on the content and format of labeling statements of ingre...

Magellan Guilty Plea Over Misbranded Devices

[ Price : $8.95]

Magellan Diagnostics pleads guilty in federal court to criminal charges arising from its concealment of a device malfunction that ...

Carvykti Improves Survival in Phase 3 Trial: J&J

[ Price : $8.95]

J&J touts positive overall survival results of its Carvykti in a Phase 3 trial in patients with relapsed or lenalidomide-refractor...

Checkpoint Resubmits Cosibelimab BLA

[ Price : $8.95]

Checkpoint Therapeutics says it has completed the resubmission of a BLA for its cosibelimab cancer treatment.

FDA OKs Pyzchiva as Stelara Biosimilar

[ Price : $8.95]

FDA approves Samsung Bioepis Pyzchiva as an interchangeable biosimilar for Janssens Stelara.

FDA OKs Genentechs Vabysmo Syringe

[ Price : $8.95]

FDA approves a Genentech Vabysmo prefilled syringe to treat three retinal disorders with the same medicine as Vabysmo vials.