Drug Review Dossiers

Drug Review Dossier: dolutegravir

The FDA/CMS Summit for Biopharma Executives 2012: Summary Notes From December 10-11 Conference

FDA’s OTC Switch Initiative: Slide Deck Attached

The User’s Guide to PDUFA V (PDF Attached)

FDA and AIDS: An Overview — Slide Presentation

Drug Review Dossier: cysteamine bitartrate

Drug Review Dossier: cobicistat

Drug Review Dossier: bedaquiline

Drug Review Dossier: Elvitegravir

Drug Review Dossier: canagliflozin

Drug Review Dossier: Kynamro

Drug Review Dossier: enzalutamide

Drug Review Dossier: Xarelto to Reduce the Risk of Stent Thrombosis in ACS

Drug Review Dossier: Xarelto for DVT, PE, prevention of VTE

Drug Review Dossier: Zohydro

Drug Review Dossier: pomalidomide

Drug Review Dossier: CRTX 800

Drug Review Dossier: lomitapide

Drug Review Dossier: BG-12

Drug Review Dossier: IPX066

Drug Review Dossier: tafamidis meglumine

Drug Review Dossier: crofelemer

Drug Review Dossier: pertuzumab

Drug Review Dossier: Gattex

Drug Review Dossier: bosutinib

Drug Review Dossier: perampanel

Drug Review Dossier: mifepristone for Cushing’s

Drug Review Dossier: apixaban

Drug Review Dossier: Marqibo

Drug Review Dossier: peginesatide

Drug Review Dossier: Axitinib

Drug Review Dossier: Aubagio

Drug Review Dossier: ridaforolimus

Drug Review Dossier: tofactinib

Drug Review Dossier: Northera

Drug Review Dossier: Eylea

Drug Review Dossier: Linaclotide

Avastin Takeaways: Prevision Policy Powerpoint Presentation

Drug Review Dossier: Alogliptin; Fixed-Dose Alogliptin/Pioglitazone Combo

Drug Review Dossier: Aclidinium

Drug Review Dossier: ruxolitinib

Drug Review Dossier: avanafil

Drug Review Dossier: Relistor for OIC in Non-Cancer Pain

Drug Review Dossier: vismodegib

Drug Review Dossier: Xarelto for AFib

Drug Review Dossier: dapagliflozin

Drug Review Dossier: Avastin for Breast Cancer

Drug Review Dossier: mirabegron

Drug Review Dossier: Benlysta

Drug Review Dossier: pixantrone

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