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Regulatory Affairs / Drug Approvals News

The latest Regulatory Affairs News & Drug Approvals News articles published daily. Includes news on FDA approvals, EMEA approvals and other regulatory issues. Category added August 2007.

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Latest News

Advanced Prostate Cancer Drug Xofigo Approved By FDA
17 May 2013
Xofigo (radium Ra 223 dichloride) has been approved by the US FDA for symptomatic late-stage (metastatic) castration-resistant prostate cancer that has reached bones but not other organs, i.e. with no known visceral metastatic disease... [read article]

Ilaris® Approved By FDA To Treat Active Systemic Juvenile Idiopathic Arthritis, A Serious Form Of Childhood Arthritis
14 May 2013
Ilaris® (canakinumab) is the first interleukin-1 beta inhibitor for the treatment of SJIA and the only treatment approved specifically for SJIA that is given as a monthly subcutaneous injection1... [read article]

New Inhaler Drug Approved By FDA For Chronic COPD
12 May 2013
The U.S. Food and Drug Administration has just announced the approval of a form of new long-term treatment for patients suffering from chronic obstructive pulmonary disease (COPD)... [read article]

Regulatory Affairs / Drug Approvals News Articles Archive  -   Page 1

08 May 2013

Ceramax® Total Hip System With Biolox® Delta Ceramic-On-Ceramic 36mm Large Femoral Head Receives FDA PMA Supplement Approval
SUSTIVA® (Efavirenz) Receives US FDA SNDA Approval For Use In HIV-1 Infected Pediatric Patients
07 May 2013

Tanning Bed Risks - FDA Aims To Increase Consumer Awareness
06 May 2013

New Analysis Of The Contents Of Lipstick And Lip Gloss May Cause You To Pause Before Puckering
05 May 2013

Liptruzet Approved By FDA To Cut Cholesterol, Despite Criticism By Cardiologists
01 May 2013

Morning After Pill Available Over The Counter For Females Over 15
FDA Approves Kcentra For Acute Bleeding
27 April 2013

Pfizer's Arthritis Drug Xeljanz (tofacitinib) Receives A Negative Opinion In Europe
20 April 2013

FDA Advisory Committee Recommends Approval Of BREO(TM) ELLIPTA(TM) For The Treatment Of COPD
18 April 2013

FDA Approves FibroScan(R) For Non-Invasive Liver Diagnosis
17 April 2013

Reformulated OxyContin To Receive Abuse-Deterrent Labelling
15 April 2013

Stimulant DMAA Potentially Dangerous To Health, FDA Warns
Avandia Safety Being Reconsidered By FDA Panel
10 April 2013

Bavarian Nordic Agrees On Interim Analysis With The FDA And Provides An Update On Its PROSPECT Phase 3 Trial
09 April 2013

InVivo Therapeutics Receives Approval From FDA For First Human Trial Using Biomaterials For Traumatic Spinal Cord Injury
03 April 2013

New Drug Application Submitted To FDA For Simeprevir (TMC435) For Combination Treatment Of Adult Patients With Genotype 1 Chronic Hepatitis C
01 April 2013

Novartis Loses In Patent Court Ruling, India
31 March 2013

Invokana (canaglifozin) For Type 2 Diabetes Approved By FDA
29 March 2013

FDA Approves Dotarem® (Gadoterate Meglumine), First Macrocyclic And Ionic Gadolinium-based Contrast Agent In USA
Tecfidera Approved For Multiple Sclerosis By FDA
26 March 2013

Negative NICE Decision For Avastin® (Bevacizumab) Highlights Challenges Facing UK Access To Medicines
24 March 2013

Titan's Implant For Treating Opioid Dependence - FDA Panel Gives A Cautious 'Yes'
23 March 2013

More Oversight Of AEDs Proposed By FDA
FDA Approves Dotarem® (Gadoterate Meglumine), First Macrocyclic And Ionic Gadolinium-Based Contrast Agent In USA
22 March 2013

Esbriet® (Pirfenidone) Receives Positive Final Appraisal Determination From NICE For Idiopathic Pulmonary Fibrosis (IPF)
20 March 2013

Mold Contaminated Medication Prompts FDA Recall
Knee Implant GelrinC Receives European CE Mark Approval
19 March 2013

Vitreomacular Traction Treatment JETREA(R) Gains EU Approval
European Commission Approves New Pre-Treatment Options For QUTENZA™ (8% Capsaicin Patch) In Peripheral Neuropathic Pain
15 March 2013

FDA Investigates Safety Of Type 2 Diabetes Drugs Januvia And Byetta
How The Tobacco Industry May Have Evaded FDA Ban On 'Light' Cigarette Descriptors
12 March 2013

EU Bans Sale Of Cosmetics Tested On Animals
11 March 2013

Physicians Should Not Be Responsible For Prescribing Marijuana: Editorial
09 March 2013

Cancer Immune Therapy AV0113 Receives Orphan Drug Designation
05 March 2013

Inappropriate Use Of Opioids, FDA Extremely Concerned
ZALTRAP® (Aflibercept) Is Now Available In The UK For The Treatment Of Advanced Metastatic Colorectal Cancer (mCRC)
03 March 2013

Dealing With Medication Errors - EMA Calls For Coordinated EU Approach
02 March 2013

Medtronic Announces CE Mark For Engagertm Transcatheter Valve
01 March 2013

Medtronic Gains First FDA Approval To Conduct Early Feasibility Medical Device Study
28 February 2013

FDA Suspends Sensipar Trials Following Death Of Teenager
27 February 2013

Drug Treating Sexual Pain Among Postmenopausal Women Approved By FDA
26 February 2013

Lupin Receives FDA Approval For New Drug Application For SUPRAX® Oral Suspension, 500 Mg/5mL
FDA Permits Production Of Generic Heroin Drug Against Bid Of Reckitt
25 February 2013

Omontys, Anemia Drug For Kidney Dialysis Patients, Recalled
22 February 2013

Kadcyla For Late-Stage Breast Cancer Approved By FDA
19 February 2013

Novartis Drug Zortress® Is First In Over A Decade Approved By FDA To Prevent Organ Rejection In Adult Liver Transplant Patients
U.S. FDA Approval Of Aorfix™
16 February 2013

GSK Receives Priority Status For New HIV Drug
13 February 2013

NICE Issues Preliminary Guidance To Not Recommend Jakavi™ In The Treatment Of Rare Blood Cancer As Not Cost-Effective
12 February 2013

Apogenix Receives FDA Orphan Drug Designation For Apocept(TM) To Treat Myelodysplastic Syndromes And Initiates Clinical Phase I Study
11 February 2013

Implementation Of Fizzy Drinks Tax Is 'Essential', Claims Charity
Pomalyst (pomalidomide) For Advanced Multiple Myeloma Approved By FDA
09 February 2013

EMA Begins Safety Review Of Acne Drug Diane 35
08 February 2013

Aripiprazole (ABILIFY®) Approved For The Treatment Of Moderate To Severe Manic Episodes In Bipolar I Disorder In Adolescents
Study Of Brain Cooling And Clot-Busting Drug Therapy For Stroke Receives FDA OK To Expand
ZALTRAP® (Aflibercept) Approved In The EU For Patients With Previously Treated Metastatic Colorectal Cancer
07 February 2013

FDA Clears Sculptor Robotic Guidance Arm™ For Unicompartmental Knee Replacement Surgery
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