Regulatory

Biodel Announces Name Change for Lead Product Candidate

September 01, 2010

Currently under review by the U.S. Food and Drug Administration
 

pSivida Announces Iluvien® Receives FDA Priority Review for Treatment of Diabetic Macular Edema

August 31, 2010

Reduces the review time goal from 10 months to six months
 

GSK and Valeant Announce New U.S. FDA PDUFA Goal Date for Ezogabine

August 30, 2010

Original PDUFA goal date was August 30, 2010
 

FDA Accepts Sanofi Pasteur's Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers

August 26, 2010

New Indication Seeks to Help Protect Infants and Toddlers Against Meningococcal Disease
 

FDA panel recommends broader use of Eli Lilly's Cymbalta

August 20, 2010

Committee votes positively regarding the overall safety profile of Cymbalta
 

DUSA Pharmaceuticals Receives Response From FDA on Orphan Drug Designation Status

August 06, 2010

Orphan Drug Designation must target a disease that affects fewer than 200,000 patients in the U.S.
 

Prochymal New Drug Submission Granted Priority Review by Health Canada

July 21, 2010

Health Canada to add first-in-class stem cell therapy to Register of Innovative Drugs providing eight years of market exclusivity
 

FDA Accepts AFREZZA Complete Response Resubmission

July 20, 2010

FDA Sets Target Action Date of December 29, 2010
 

NeuroPace Submits PMA Application for FDA Approval of Novel Investigational Device for Epilepsy

July 08, 2010

Pivotal Trial Data Demonstrate RNS System Met Primary Endpoints by Significantly Reducing Seizures with Positive Safety Profile
 

Winston Laboratories, Inc. Submits NDA for CIVANEX® (Civamide Cream) for Treatment of Osteoarthritis

July 07, 2010

Also awaiting approval in the European Union and Canada
 

Genentech Submits Application to FDA for Trastuzumab-DM1 in Previously Treated Advanced HER2-Positive Breast Cancer

July 07, 2010

T-DM1 is the First Antibody-Drug Conjugate in Genentech's Pipeline to Be Submitted to the FDA
 

FDA Approves New Roche Dual-PCR Target HIV-1 Test

June 04, 2010

First dual-PCR target viral load test approved for monitoring HIV patients receiving antiretroviral therapy
 

FDA Approves Amgen's Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis

June 01, 2010

Given As An Injection Every Six Months, Prolia Reduced Risk Of Fracture At The Spine, Hip And Other Sites
 

Horizon Pharma, Inc. Announces FDA Acceptance of DUEXA(R) New Drug Application for Filing

May 26, 2010

FDA's completed review for DUEXA is expected in the first quarter of 2011
 

Allergan Receives FDA Approval for ZYMAXID Ophthalmic Solution

May 19, 2010

Effective against a broad spectrum of gram-positive and gram-negative pathogens
 

Sigma-Tau Pharmaceuticals Cysteamine Eye Drop NDA Accepted for Filing

May 17, 2010

Cystinosis Treatment Granted Priority Review Status
 

ROXRO Announces FDA Approval of SPRIX(TM)

May 17, 2010

First Non-narcotic Intranasal Analgesic for Moderate to Moderately Severe Pain
 

Sagent Pharmaceuticals Announces FDA Approval of Bacitracin for Injection, USP

May 12, 2010

Seventh product approved from Sagent's partnership with Strides Arcolab
 

FDA Approves Cefepime for Use In B. Braun's DUPLEX(R) System

May 11, 2010

Company Meets Customer Demands for Safe, Accurate and Efficient Drug Delivery
 

U.S. FDA Approves Natazia(TM)

May 07, 2010

A New Oral Contraceptive for the Prevention of Pregnancy
 

BioSante Pharmaceuticals Announces Reinitiation of Prostate Cancer Vaccine Development

May 03, 2010

Regulatory steps to lift the GVAX Prostate clinical hold are being taken
 

FDA Approved VIMOVO(TM) for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers

April 30, 2010

New treatment option offers pain relief with a built-in proton pump inhibitor (PPI)
 

Takeda Submits New Drug Application for Azilsartan Medoxomil in the U.S.

April 27, 2010

An Investigational Compound for the Treatment of Hypertension
 

Merz Aesthetics Announces FDA Approval of Asclera(TM) (Polidocanol) Injection

April 23, 2010

First Sclerosant to Treat Small Varicose Veins in 60 Years
 

Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM)

April 22, 2010

Classification of Submission and New PDUFA Action Date Expected Within 14 Days, per FDA Guidelines
 

Novartis Receives US FDA Approval for Zortress(R) (everolimus)

April 22, 2010

Prevents Organ Rejection in Adult Kidney Transplant Recipients
 

FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer

April 16, 2010

First Maintenance Therapy Approved For a Broad Patient Population Including Squamous and Non-Squamous Histology
 

FDA Approves New Drug Application for PANCREAZE(TM)

April 13, 2010

Pancreatic Enzyme Therapy Approved by FDA to Treat Exocrine Pancreatic Insufficiency
 
 

Baxter and Nycomed Announce FDA Approval of TachoSil®

April 06, 2010

TachoSil indicated for use as an adjunct to hemostasis in cardiovascular surgery
 

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