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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FDA: Boxed Warning On Serious Mental Health Events To Be Required For Chantix And Zyban

05 July 2009

The U.S. Food and Drug Administration announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion)...
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FDA Approves Multaq To Treat Heart Rhythm Disorder

05 July 2009

The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders)...
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Watson Pharmaceuticals Receives FDA Approval For Generic PLAN B(R)

04 July 2009

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug...
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Regulatory Affairs / Drug Approvals News Articles Archive - Page 1

04 July 2009

Stanford Bioethicist And Colleagues Call For Federal Regulation Of Genetic Ancestry Testing

03 July 2009

FDA Adds Strong Warnings To Anti-Smoking Drug Labels

FDA Approves Multaq(R) For Patients With Atrial Fibrillation Or Atrial Flutter

Acura And King Receive FDA Complete Response Letter Regarding Acurox(R)

02 July 2009

FDA Panel Votes To Restrict Acetaminophen

POZEN Submits New Drug Application For VIMOVO™ (PN 400)

Medarex To Receive Milestone Payment For The Approval Of Ilaris For The Treatment Of Cryopyrin-Associated Periodic Syndrome

Teva Announces Approval And Launch Of Tri-Lo Sprintec Tablets

FDA Approves Feraheme™ To Treat Iron Deficiency Anemia In Adult Chronic Kidney Disease Patients

CytRx Files Report With The FDA In Response To The Partial Clinical Hold On Its Phase 2b Arimoclomol ALS Trial

Aclasta(R) (zoledronic Acid 5mg) Approved In EU To Treat Steroid Induced Osteoporosis In Men And Post-menopausal Women

01 July 2009

FDA Seeks Public Input On Tobacco Regulation

PPD Confirms Takeda Receives FDA Complete Response For Alogliptin

ABRAXANE Approved For Advanced Breast Cancer Patient Treatment In Quebec

Teva And Antares Announce FDA Approval Of Needle-Free Injector Product For Administration Of Tev-Tropin(R) (Human Growth Hormone)

New Data: Efficacy And Responder Analyses Of Divigel(R) (estradiol Gel) 0.1 Percent For The Treatment Of Menopause

Enigma Diagnostics Announces Successful Evaluation Of The Enigma FL By The UK's Veterinary Laboratories Agency

Cephalon Submits NUVIGIL Supplemental New Drug Application For The Treatment Of Excessive Sleepiness Associated With Jet Lag Disorder

Medical Device Development: Stanford Researchers Publish Comprehensive Model

30 June 2009

FDA Confirms E. Coli O157:H7 In Prepackaged Nestlé Toll House Refrigerated Cookie Dough

Vietnamese Drug Authority Teams With United States Standards-Setting Organization

European Medicines Agency Update On Safety Of Insulin Glargine

Takeda Receives FDA Complete Response Letter For Alogliptin, An Investigational Treatment For Type 2 Diabetes

Sinovac Receives Revised Approvals For Panflu

E Coli Confirmed In Nestlé Toll House Cookie Dough Says FDA

Company Recalls Various Products Due To Potential Salmonella Contamination

FDA Grants LUCAS™ 2 Chest Compression System 510(k) Clearance In The United States

29 June 2009

European Medicines Agency Recommends Withdrawal Of Dextropropoxyphene-Containing Medicines (Including Co-Proxamol)

UCB Brings Neupro(R) Back To All Patients In Europe

European CHMP Adopts Positive Opinion For Aztreonam Lysine

Drug Companies Increasingly Use Medical Science Liaisons

Proportion Of Fatal Crashes Increases

28 June 2009

CHMP Recommends 'Januvia(R)'(sitagliptin), From MSD, For Restricted First Line Use In European Union

27 June 2009

Positive CHMP Opinion For JAVLOR(R) In Metastatic Treatment Of Bladder Cancer After Failure Of A Prior Platinum-Containing Regimen

Experts: Big Tobacco Dead By 2047, Possibly Sooner

26 June 2009

Cimzia(R), The Only PEGylated Anti-TNF, Recommended For Approval In The EU For Rheumatoid Arthritis

Mylan Receives FDA Approval For Additional Strength Of Generic Restoril(R)

European Medicines Agency Recommends First Marketing Authorisation For Cell-Based Medicine That Repairs Femoral Condyle Cartilage Defects

FDA Approves Generic Version Of Emergency Contraception Pills

U.S. Marshals Seize Drug Products Manufactured By Caraco Pharmaceutical Laboratories Ltd. FDA Acts To Prevent Repeated Drug Quality Problems

Vetericyn Inc. Launches Equine Wound & Infection Product Utilizing FDA-Cleared Technology

European Medicines Agency Recommends Withdrawal Of Dextropropoxyphene-containing Medicines

Supply Shortages Of Cerezyme And Fabrazyme - Priority Access Forpatients Most In Need Of Treatment Recommended

Frankenman International Ltd Secures FDA Clearance For Its Entire CHEX Range Of Surgical Staplers

25 June 2009

FDA Approves Generic Prescription-Only Version Of Plan B Emergency Contraceptive For Women Ages 17 And Under

Apthera Receives Special Protocol Assessment (SPA) From FDA For Pivotal Phase III Trial Of NeuVax In Early-Stage Breast Cancer

Spectranetics Receives CE Mark Approval For ThromCat(R)XT

Caldera Medical Announces FDA Clearance Of Novel Treatment For Pelvic Organ Prolapse

24 June 2009

FDA Seeks Public Input On Transparency

Vacci-Test Receives U.S. Approval For FoodChekTM-E.Coli Test

CorNova(R) Receives CE Mark Approval For Valecor Platinum(R) Coronary Stent System

Abbott Receives CE Mark For Company's Next-Generation XIENCE PRIME(TM) Drug Eluting Stent, Advancing Leadership Position

Menarini International Operations Luxembourg Withdraws Its Marketing Authorisation Application For Factive (gemifloxacin), Europe

FDA Approves Cambia™ For Migraine

23 June 2009

FDA Warns Consumers Not To Eat California Prime Produce And Orange County Orchards Brands Of Pistachios

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) For The Treatment Of Fabry Disease

Biomodels' Oral Mucositis Expertise Speeds FDA Approval For ActoGeniX's Phase 1b Trial Of AGO13 In Cancer Patients

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