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Arrow Recalls FiberOptix Intra-Aortic Catheter

[ Price : $8.95]

Arrow International recalls (Class 1) its Arrow FiberOptix Intra-Aortic Balloon Catheter Kit after receiving reports about infrequ...

3 Comments on BA/BE Data Integrity Guidance

[ Price : $8.95]

Three stakeholders give technical suggestions to change an FDA draft guidance on data integrity for in vivo bioavailability and bi...

Little Debarred Over Unapproved Drugs

[ Price : $8.95]

Federal Register notice: FDA issues an order debarring Michael Terry Little for five years from importing or offering for import a...

Agios Filing NDA on Thalassemia Drug

[ Price : $8.95]

Agios Pharmaceuticals plans to submit by the end of the year an NDA for mitapivat and its use on adults with transfusion-dependent...

Partial Hold on Blueprints Cancer Drug

[ Price : $8.95]

FDA places a partial clinical hold on a Blueprint Medicines early-stage trial testing its experimental cancer drug because of safe...

Takeda Moving Narcolepsy Drug to Phase 3

[ Price : $8.95]

Takeda says it is moving its narcolepsy Type 1 drug TAK-861 to a Phase 3 trial after reporting positive results from a Phase 2b tr...

FDA Clears Kenota Health IgE Test

[ Price : $8.95]

FDA clears a Kenota Health 510(k) for its Kenota 1 Total IgE [immunoglobulin E] test system.

FDA Debars Punjani Over Imported Generic Viagra

[ Price : $8.95]

Federal Register notice: FDA debars Shanif Abdul Punjani for five years from importing or offering for import any drug into the U....

FDA Extends Review of Dupixent in COPD

[ Price : $8.95]

FDA extends by three months its review of a Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment...

Final Rule Allows Imported Device Destruction

[ Price : $8.95]

Federal Register final rule: FDA issues a regulation to implement its authority to destroy a device valued at $2,500 or less that ...