FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Wants More Data from Sarepta on Duchenne Drug

[ Price : $8.95]

FDA deals Sarepta Therapeutics another blow by asking for additional data to be included in the companys planned NDA for eteplirse...

FDA OKs St. Jude Medical TactCath Quartz Ablation Catheter

[ Price : $8.95]

FDA approves a St. Jude Medical PMA for its TactiCath Quartz irrigated ablation catheter, a real-time objective measure of the for...

CBER Guide on Same Surgical Procedure Under HCT/P Rule

[ Price : $8.95]

A new CBER draft guidance outlines certain exemptions for procedures involving human cells, tissues or cellular or tissue-based pr...

FDA Approves Baxter BLA for Acquired Hemophilia A Therapy

[ Price : $8.95]

FDA approves a Baxter Healthcare BLA for Obizur [antihemophilic factor (recombinant), porcine sequence] for treating bleeding epis...

FDA Grants MediciNova Orphan Status for IPF Drug

[ Price : $8.95]

FDA grants MediciNova an orphan-drug designation for MN-001 (tipelukast) for treating idiopathic pulmonary fibrosis.

Rich Pharma Submits IND to FDA for Blood Diseases

[ Price : $8.95]

Rich Pharmaceuticals submits an IND application to FDA for a Phase 2 clinical trial of its RP-323 in patients with acute myelocyti...

Dallas Jury Clears J&J Unit in Hip Implant Case

[ Price : $8.95]

A Dallas jury finds that Johnson & Johnsons DePuy unit did not market defective metal-on-metal hip implants.

FDA Draft Guidance on Use of Biomarker Galactomannan

[ Price : $8.95]

FDA releases a draft guidance on Qualification of Biomarker Galactomannan in studies of treatments of Invasive Aspergillosis that...

FDA Warning Letter on Hikma Pharmas Portugal Plant

[ Price : $8.95]

FDA issues a Warning Letter to Hikma Pharmaceuticals, citing GMP issues related to environmental monitoring at its plant in Portug...

Biogen Idec Confirms 1st PML Case with New Multiple Sclerosis Drug

[ Price : $8.95]

Biogen Idec confirms the first case of progressive multifocal leukoencephalopathy associated with a patient taking the companys ne...