Regulatory Affairs News & Drug Approvals News from Medical News Today

Regulatory Affairs / Drug Approvals News

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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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New Guidelines Released By The International Society For Stem Cell Research

04 December 2008

The International Society for Stem Cell Research (ISSCR), the world's leading professional organization of stem cell researchers, released new guidelines for the responsible development of safe and effective stem cell therapies for patients...
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European Commission Approval Of New Indication For Pegasys(R) (peginterferon Alfa-2a) Offers Hepatitis C Patients A Second Chance For A Cure

04 December 2008

Pegasys is the first and only pegylated interferon to be approved for treatment of up to 72 weeks in treatment-experienced patients. Roche announced today that the European Commission has approved Pegasys®...
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New York Times Examines British Cost-Effective Treatment System; Could Become Model For U.S.

04 December 2008

The New York Times on Tuesday, in an occasional series called "The Evidence Gap," examined Britain's National Institute for Health and Clinical Excellence, which determines the cost-effectiveness of medication and treatments...
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Regulatory Affairs / Drug Approvals News Articles Archive - Page 1

04 December 2008

Alcon Announces AZARGA(R) Ophthalmic Suspension Approved For Treatment Of Patients With Glaucoma Or Ocular Hypertension In The European Union

Genta Receives Complete Response Letter From FDA To Amended Application Of Genasense(R) In Patients With Chronic Lymphocytic Leukemia

U.S. FDA Grants Orphan Drug Designation For Burzynski Research Institute's Antineoplaston Treatment For Gliomas

Thermo Fisher Scientific Launches Program To Meet Melamine Detection Challenges

Bionovo Announces Development Plans For Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings

Advanced Life Sciences Announces Cethromycin NDA Accepted For Filing By FDA For The Treatment Of Community Acquired Pneumonia

03 December 2008

PharmaEngine Receives Approval Of US IND Application For A Phase II Study Of PEP02 (Liposome Irinotecan Injection) In Pancreatic Cancer

PREZISTA(R) (darunavir) Receives Expanded Marketing Authorisation In The European Union For Treatment-Experienced Adults With HIV-1

Wyeth Submits European Marketing Authorization Application For 13-Valent Vaccine For The Prevention Of Pneumococcal Disease In Infants

U.S. Naval Medical Research Center Resubmits IND Application For Proposed 'Op RESUS' Clinical Trial In Trauma Patients In The Battlefield Setting

02 December 2008

U.S FDA Grants Pralatrexate Orphan Drug Designation For The Treatment Of Patients With Follicular Lymphoma

Ark Files Cerepro(R) Application For Marketing Authorisation With EMEA

FDA Approves Duramed's Synthetic Conjugated Estrogens A Vaginal Cream

01 December 2008

Merck Serono: European Commission Approves Erbitux For 1st-Line Use In Head And Neck Cancer

IMPAX Receives Final FDA Approval For Generic Wellbutrin(R) XL 150 Mg

Pharmaceuticals Sector Interim Report: European Commission Attacks Practices That Prevent Competition From Generic Drugs

29 November 2008

Lilly Withdraws Application For Additional U.S. Indication For Cymbalta(R) For Chronic Pain

VIDA Diagnostics Gains FDA Approval For Comprehensive Lung Analysis Software

28 November 2008

New Biologic Ustekinumab Receives Positive Opinion From European Regulatory Authority For The Treatment Of Moderate To Severe Plaque Psoriasis

Nplate(TM) (Romiplostim) Receives Positive Opinion For Marketing Authorisation In The European Union

Tapentadol Immediate Release Tablets Approved For The Treatment Of Moderate To Severe Pain By FDA

27 November 2008

Study Questions Safety, Efficacy For Off-Label Uses Of Prescription Drugs

In Wake Of FTC Ruling Today, Lautenberg, Snowe Hail End Of Decades Of Tobacco Industry Lies, USA

New HIV/AIDS Treatment SELZENTRY™ Becomes The Latest Fully Approved Antiretrovial For Treatment-Experienced HIV Patients

PLC Systems Receives Full FDA Approval For Pivotal Study Of RenalGuard(TM) In The U.S.

FDA Issues Complete Response Letter For Ceftobiprole For Treatment Of Complicated Skin Infections

Genentech Issues Dear Healthcare Provider Letter Regarding A 2nd Case Of PML In A Raptiva Patient

Sandoz Receives Positive EU Opinion For Biosimilar Filgrastim

26 November 2008

Some Asians Taking Certain Epilepsy Medications Might Experience Adverse Skin Reactions, FDA Says

Massachusetts Attorney General Urges Congress To Support The Protecting Patients And Healthcare Act

FDA Approves New Drug To Alleviate Moderate To Severe Pain

25 November 2008

OrBec(R) Receives Orphan Drug Designation In Australia For The Treatment Of Gastrointestinal Graft-Versus-Host-Disease

U.S. Approval For Clolar(R) To Treat Adult Acute Myeloid Leukemia Sought By Genzyme

Chorea Associated With Huntington's Disease Ovation - Nationwide Availability Of Xenazine (tetrabenazine) Tablets In U.S.

Medicaid Paid Nearly $198M For More Than 100 Unapproved Drugs From 2004-2007, According To AP Analysis

Clot Risk Increased By Transfusions In Hospitalized Cancer Patients

Antibiotic-Resistant Organisms Could Be Spread By The Transporting Of Broiler Chickens

FDA Grants Pralatrexate Orphan Drug Designation For The Treatment Of Patients With Diffuse Large B-Cell Lymphoma

Key US Patent Granted On Antibodies Against GM-CSF To Treat Inflammatory Disorders (Rheumatoid Arthritis)

Commercialisation Of Yondelis(R) For The Treatment Of Soft Tissue Sarcoma Approved In Russia

New Biologic Ustekinumab Receives Positive Opinion From European Regulatory Authority For The Treatment Of Moderate To Severe Plaque Psoriasis

Arthritis Advisory Committee Recommends FDA Approval Of Febuxostat For The Treatment Of Hyperuricemia In Patients With Gout

14 Drugs Identified As Most Urgently Needing Study For Off-label Use, Stanford Professor Says

New Study Finds Publication Bias Among Trials Submitted To FDA

24 November 2008

NICE Admits Previous Guidance Around Sequential Use Of Anti-TNF Therapies In Rheumatoid Arthritis Unfair

FDA Accepts Filing And Grants Priority Review For DX-88 For Hereditary Angioedema

Severe Epilepsy Drug Banzel Wins FDA Approval

23 November 2008

Novel Antidepressant Valdoxan(R), Receives EMEA CHMP Positive Opinion For Major Depressive Episodes

Final Rule Issued For Patient Safety Organization, US Department Of Health

Rasilez HCT(R) Receives Recommendation For European Approval As A Single-pill Combination To Treat High Blood Pressure

FDA To Share Perspective On Polymorphic Forms In Abbreviated New Drug Applications - 6th Annual IQPC Polymorphism & Crystallisation Conference

Connecticut Is First State In The Nation To Enact Allergy Safeguards For Olive Oil

22 November 2008

CHMP Recommends Approval Of New Indication For Enbrel(R) As Treatment For Severe Psoriasis In Paediatric Patients

FDA Approves Promacta(R) (Eltrombopag), The First Oral Medication To Increase Platelet Production For People With Serious Blood Disorder

Arpida Comments On FDA's Anti-infective Drugs Advisory Committee Outcome

FDA Approves Tapentadol Immediate-Release Tablets For Relief Of Moderate To Severe Acute Pain

21 November 2008

FDA Approves New Drug To Treat Severe Form Of Epilepsy

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