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Law Firm Hires Former CDRH Branch Chief

[ Price : $8.95]

King & Spalding hires former CDRH Neurodiagnostic And Neurosurgical Devices Branch chief Quynh T. Hoang as a senior regulatory con...

Emergent Bio sBLA for Anthrax Vaccine

[ Price : $8.95]

Emergent BioSolutions files a supplemental BLA seeking approval to expand the label of BioThrax (anthrax vaccine adsorbed) to incl...

FDA Accepts Amgen BLA for High Cholesterol Therapy

[ Price : $8.95]

FDA accepts for review an Amgen BLA for evolocumab for treating high cholesterol.

FDA Grants RedHill Biopharma QIPD Status for RHB-105

[ Price : $8.95]

FDA grants RedHill Biopharma a Qualified Infectious Disease Product designation for its Helicobacter pylori eradication therapy, R...

Comments Sought on Finished Pharmaceutical CGMPs

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Federal Register Notice: FDA invites comments on a proposed collection of information on CGMPs for finished pharmaceuticals.

Santos Debarred for 12 Years

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Federal Register Notice: FDA issues an order under the FD&C Act debarring Armando Santos from providing services to a person that ...

Panels to Meet on Investigational Drug

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Federal Register Notice: FDAs Bone, Reproductive and Urologic Drugs and the Drug Safety and Risk Management Advisory Committee wil...

Avanir Expects Review Extension on Migraine NDA

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Avanir says it expects a review extension on an NDA for AVP-825, a drug-device combination of low-dose sumatriptan powder that is ...

Panel to Discuss Cerexa for Intra-abdominal/UTIs

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 12/5 to discuss a Cerexa Inc. NDA to treat complic...

FDA Panel Backs Rockwells Triferic in Hemodialysis Patients

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FDAs Oncologic Drugs Advisory Committee votes 8 to 3 to support the approval of Rockwell Medicals Triferic for treating iron loss ...