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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

Median Survival Time Nearly Doubled By Newly Approved Drug For Metastatic Melanoma
23 February 2012
Researchers from UCLA's Jonsson Comprehensive Cancer Center, together with scientists from 12 other sites in the United States and Australia, report for the first time that a newly approved drug for patients with metastatic... [read article]

Endogenous Cushing's Syndrome - FDA Approves Korlym (Mifepristone)
22 February 2012
The U.S. Food and Drug Administration has approved Korlym (mifepristone) to control hyperglycemia (high blood sugar levels) in adults with endogenous Cushing's syndrome, who have type 2 diabetes or glucose intolerance, who... [read article]

Fake Drugs Increasing On The Net And Finding Their Way Into Legitimate Supplies
22 February 2012
Fake drugs are increasingly being sold on the Internet in a global counterfeit medicines market that has doubled in the last five years to more than $75 million. The medicines, many of which are life-threatening, have... [read article]

Regulatory Affairs / Drug Approvals News Articles Archive  -   Page 1

21 February 2012

Zelboraf (vemurafenib), For Deadly Skin Cancer, Approved In Europe
Risk Of Seizures May Increase With Swap To Generic Antiepileptic Drugs
19 February 2012

Qnexa Obesity Drug - FDA Concerned About Long-term Side Effects
17 February 2012

Repeat Prostate Biopsies - PROGENSA® PCA3 Assay Helps Determine, Approved By FDA
15 February 2012

Fake Avastin (Bevacizumab) Found In USA
14 February 2012

Biosimilar Product Development - FDA's Draft Guidance
New Glaucoma Drug Zioptan Wins FDA Approval
13 February 2012

In Mouse Model Bexarotene Quickly Reverses Alzheimer's Symptoms
12 February 2012

Childhood Leukemia Drug, Methotrexate, In Short Supply
10 February 2012

Lisdexamfetamine Dimesylate Approved For ADHD In Adults, USA
Obesity Drug 'Mediator' Likely Responsible For Thousands Of Hospitalizations And Deaths In France
09 February 2012

Big Drop In Trans-Fats In US Bloodstream
08 February 2012

Proton Pump Inhibitors Raise Persistent Diarrhea Risk, Warns FDA
03 February 2012

Pharmaceutical Legislation Changes In Europe - EMA and Member States Prepare
Sugar Should Be Regulated Like Alcohol And Tobacco Say Scientists
02 February 2012

Medical Device Industry And FDA Reach Provisional Fees Agreement
Carbendazim In Orange Juice - FDA Informs Juice Products Association
In Patients With Drug-Resistant Prostate Cancer, New Drug Extends Survival
01 February 2012

Erivedge - Treatment For Most Common Form Of Skin Cancer
FDA Approves Drug For Common Skin Cancer
31 January 2012

Kalydeco - A Cystic Fibrosis Treatment
Nutrition Labels Being Ignored By Consumers
29 January 2012

Amylin's Once-Weekly Diabetes Injection Finally Wins FDA Approval
27 January 2012

Inlyta (axitinib) Approved For Advanced Kidney Cancer, USA
Keppra® Approved By FDA For Childhood Seizures
23 January 2012

Ban Cosmetic Surgery Ads, Regulate The Industry, Urge To UK Government
Communicating Health Risk Is A Risky Task For FDA
21 January 2012

New Drug Labels For Kidney Disease Patients
11 January 2012

Orange Juice - FDA Concern Regarding Banned Fungicide
05 January 2012

FDA Bans Certain Uses Of Antibiotics In Food-Producing Animals
04 January 2012

Parents Should Read Infant Acetaminophen Labels Carefully Urges FDA
03 January 2012

FDA Approves Shared REMS (Risk Evaluation And Mitigation Strategy) Program For All TIRF (Transmucosal Immediate Release Fentanyl) Pain Treatments
ONSOLIS To Benefit From Approval Of Class-Wide REMS For All Transmucosal Fentanyl Products
FDA To Approve Shared System REMS For TIRF Products
01 January 2012

TriReme Medical, Inc. Receives FDA 510(K) Clearance For Chocolate PTA Balloon Catheter
VIVUS Announces Date Of FDA Advisory Committee Review Of Qnexa For The Treatment Of Obesity
Janssen Research & Development Submits Application To U.S. FDA For XARELTO® (rivaroxaban) To Reduce Secondary Cardiovascular Events
Double Check Dose Before Giving Acetaminophen To Infants, FDA
31 December 2011

FDA To Review Potential New Use Of XGEVA® (Denosumab) At Oncologic Drugs Advisory Committee Meeting
29 December 2011

Durezol And Durasal, Don't Get Them Mixed Up, FDA Warns
Poor Diet Of Shift Workers An "Occupational Health Hazard"
FDA Targets Risks From Reused Medical Devices
Perrigo Announces FDA Final Approval For Desloratadine
Intravenous Remodulin Approved For The Treatment Of Pulmonary Arterial Hypertension In Most Of The European Union
26 December 2011

Addition Of New Infant Acetaminophen Concentration, 160 Mg/5 ML, Says FDA
21 December 2011

FDA's Gobburu Joins University Of Maryland School Of Pharmacy Faculty
20 December 2011

FDA Collaborates To Work Against Rare Cataract Condition
19 December 2011

FDA Alert : Multaq (Dronedarone) Increased Risk Of Death / Cardiovascular Problems
Celladon Corporation Receives FDA Fast Track Designation For Its Investigational Agent MYDICAR® For The Treatment Of Heart Failure
ViroPharma Announces Approval Of Modernized Labeling For Vancocin® (vancomycin Hydrochloride, USP) Capsules
Mobile MIM Receives Second FDA 510(k) Clearance, Adds X-Ray And Radiation Oncology
Role Of Government Funding In Pharmaceutical R&D And Its Direct And Indirect Impact On Innovative New Drugs
18 December 2011

FDA Approves Hologic's Cervista High Throughput Automation System For Cervical Cancer Screening
FDA Approves Mechanical Cardiac Assist Device For Children With Heart Failure
Research Needed On 'Modified Risk' Tobacco Products, Report Concludes
16 December 2011

Bioethics And Better Protection For Human Volunteers
Roche Melanoma Drug Gets European Green Light
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