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St. Jude Recalls Unify Defibrillators Over Battery Issue

[ Price : $8.95]

St. Jude Medical recalls Unify and Unify Assura cardiac resynchronization therapy defibrillators due to battery issues.

QS and MDR Violations at Swedens Euro Diagnostica

[ Price : $8.95]

FDA warns Swedens Euro Diagnostica about Quality System and Medical Device Reporting violations in its manufacturing of Class 2 me...

QS Violations in Diasol Inspection

[ Price : $8.95]

FDA warns Diasol about QS violations in its New Jersey manufacturing and repacking facility.

Novo Nordisk Asks Liraglutide Drug ANDA Restrictions

[ Price : $8.95]

Novo Nordisk asks FDA not to approve any ANDA for a drug referencing any of its liragltide-containing drugs and put restrictions o...

Pfizer Sees Potential Guidance Conflicts

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Pfizer tells FDA that an agency draft guidance on CMC postapproval manufacturing changes for specified biological products may con...

FDA Accepts Allergan NDA for Uterine Fibroids

[ Price : $8.95]

FDA accepts an Allergan NDA for ulipristal acetate, an investigational drug for treating abnormal uterine bleeding in women with u...

FDA Rejects Mylans BLA for Neulasta Biosimilar

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FDA issues a complete response letter for Mylans BLA for MYL-1401H, a proposed biosimilar of Amgens Neulasta (pegfilgrastim).

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Diasol, Euro Diagnostica, Option Care, and Laveeza Bhatti.

FDA Priority Review for Ultragenyx/Kyowa BLA

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FDA accepts for priority review an Ultragenyx Pharmaceutical and Kyowa BLA for burosumab to treat pediatric and adult patients wit...

Reviewers Ask Tough Luxturna Questions

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FDA medical reviewers ask members of the Cellular, Tissue, and Gene Therapies Advisory Committee for their opinion on difficult qu...