Pharma News - Drug/Product Approvals News & Articles

481 Physical-chemical identifiers: a q&a with FDA on the final guidance Full Text Pharmaceutical Technology, June 22, 2012

482 Lucinactant approved for premie RDS Full Text Drug Topics, June 21, 2012

483 Watson confirms favorable appeals court decision in sanctura XR patent suit Full Text Actavis, June 19, 2012

484 Genzyme submits applications to FDA and EMA for approval of lemtrada (alemtuzumab) for multiple sclerosis Full Text Genzyme, June 15, 2012

485 Genzyme submits applications to FDA and EMA for approval of lemtrada (alemtuzumab) for multiple sclerosis Full Text Sanofi, June 13, 2012

486 FDA approves Perjeta (pertuzumab) for people with HER2-positive metastatic breast cancer Full Text Roche, June 12, 2012

487 Sanofi submits application for regulatory approval for lyxumia (lixisenatide) for the treatment of type 2 diabetes in japan Full Text Sanofi, June 12, 2012

488 Novartis drug Gilenya shows long-term efficacy and safety according to new data from extension of phase III head-to-head study Full Text Novartis, June 12, 2012

489 FDA approves perjeta (pertuzumab) for people with her2-positive metastatic breast cancer Full Text Genentech, June 11, 2012

490 Medtronic files PMA application for FDA approval of minimed 530g system featuring threshold suspend automation Full Text Medtronic, June 11, 2012

491 Perjeta approved for her2-positive metastatic breast cancer Full Text Genentech, June 11, 2012

492 Gsk and xenoport receive FDA approval for horizant for postherpetic neuralgia XenoPort, June 8, 2012

493 Pathological complete response and accelerated drug approval in early breast cancer New England Journal of Medicine, June 8, 2012

494 Ich q11 drug substance guideline has gained global approval Full Text Pharmaceutical Technology, June 8, 2012

495 Linagliptin: a novel methylxanthin based approved dipeptidyl peptidase-4 inhibitor Current Drug Targets, June 6, 2012

496 FDA approves generic versions of blood thinner Plavix Full Text Drug Topics, June 5, 2012

497 FDA adopts new strategies to oversee global economy Full Text BioPharm International, June 4, 2012

498 Usability of FDA-approved medication guides Journal of General Internal Medicine, May 31, 2012

499 New CAD/ACS antiplatelet agents a mixed bag Full Text Drug Topics, May 30, 2012

500 FDA perspectives: scientific considerations of forced degradation studies in anda submissions Full Text Pharmaceutical Technology, May 29, 2012

1 U.S. FDA Approves INVOKANA (Canagliflozin) to Treat Adults with Type 2 Diabetes Janssen, April 1, 2013    Free full text

2 FDA Approves Mercks LIPTRUZET (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol Merck, May 8, 2013    Free full text

3 FDA approves treatment for postmenopausal women experiencing pain during intercourse Drug Topics, March 7, 2013    Free full text

4 Hepatitis C Treatment Options Likely to Expand First Report Managed Care, May 20, 2013    Free full text

5 Canagliflozin: First in class for type 2 diabetes American Pharmacists Association News, May 2, 2013    Free full text

6 FDA approves Procysbi for rare genetic condition FDA Press Announcements, May 1, 2013    Free full text

7 Ospemifene: New treatment for postmenopausal women American Pharmacists Association News, April 5, 2013    Free full text

8 FDA Approves Mercks LIPTRUZET (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol Merck, May 6, 2013    Free full text

9 FDA approves ACTEMRA for children living with a rare form of arthritis Roche, May 2, 2013    Free full text

10 FDA Accepts BLA for Mercks Allergy Immunotherapy Tablet BioPharm International, May 21, 2013    Free full text

11 FDA approves Tarceva (erlotinib) tablets and cobas EGFR Mutation Test for specific type of lung cancer Roche, May 16, 2013    Free full text

12 New Stent Retriever Devices Current Atherosclerosis Reports, May 15, 2013

13 Warner Chilcott Announces FDA Approval of New Oral Contraceptive Warner Chilcott, April 25, 2013    Free full text

14 FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease FDA Press Announcements, May 13, 2013    Free full text

15 Daratumumab Granted Fast Track Designation from US Food and Drug Administration Genmab, April 3, 2013    Free full text

16 BREO ELLIPTA gains US approval for the treatment of COPD GlaxoSmithKline, May 13, 2013    Free full text

17 FDA releases new tool to help prevent intentional food contamination FDA Press Announcements, May 17, 2013    Free full text

18 Regulatory update: Trametinib US PDUFA date extended to 3 September 2013 GlaxoSmithKline, May 3, 2013    Free full text

19 FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs BioPharm International, April 18, 2013    Free full text

20 Fda approves two drugs, companion diagnostic test for advanced skin cancer FDA Press Announcements, May 30, 2013    Free full text