August 27. 2010
Genentech provides update on FDA application for T-DM1 |
August 23. 2010
FDA conducting safety review of Novartis drug Stalevo |
August 20. 2010
U.S. flu plan cuts red tape, rewards biotechs |
August 20. 2010
Avastin mugging - FDA rigs the verdict against a good cancer drug |
August 17. 2010
Biosimilar development progresses, without FDA guidelines |
August 16. 2010
FDA considers revoking approval of Avastin for advanced breast cancer |
August 12. 2010
Ezogabine, an investigational anti-epileptic drug, receives positive vote from FDA advisory committee |
August 11. 2010
Experts fear antibiotics not being advanced fast enough |
August 09. 2010
FDA warns Novartis of FDA regulation infringes |
August 05. 2010
Bayer: FDA accepts new drug application for Gadovist 1.0 injection in magnetic resonance imaging |
August 02. 2010
Senator slams FDA advisory committee's Avastin decision |
July 30. 2010
Health group sues FDA over antimicrobial soap |
July 29. 2010
Abbott's SIMCOR receives FDA approval for new dosage strengths |
July 27. 2010
Roche receives FDA clearance for CoaguChek XS Pro system with bar code reader for PT/INR testing at the point of care |
July 27. 2010
Novartis launches new Triaminic fever reducer pain reliever liquid for children as safe over-the-counter treatment option |
July 21. 2010
Genentech provides update from Avastin FDA Advisory Committee meeting |
July 09. 2010
FDA clears Roche's LightCycler(R) MRSA advanced test for use in the U.S. |
July 07. 2010
Roche submits application to FDA for trastuzumab-DM1 in previously treated advanced HER2-positive breast cancer |
June 30. 2010
FDA: Antibiotics in livestock affects human health |
June 30. 2010
U.S. FDA panel explores boost for rare drugs |
June 25. 2010
SkyePharma not hopeful for U.S. Flutiform approval |
June 25. 2010
Abbott receives FDA clearance for new, easier-to-use FreeStyle test strips |
June 23. 2010
Genentech: FDA approves Lucentis for the treatment of macular edema following retinal vein occlusion |
June 21. 2010
Boehringer Ingelheim comments on June 18th FDA Advisory Committee meeting |
June 21. 2010
Bayer: New erectile dysfunction treatment STAXYN approved in the U.S. |
June 18. 2010
FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec |
June 17. 2010
New FDA website lets public find drug safety info |
June 11. 2010
Regulators urged to help develop antibiotics |
June 09. 2010
US eyes safety of Novartis' MS drug ahead of panel |
June 01. 2010
FDA announces collaboration with Drugs.com |
May 28. 2010
Roche Diagnostics receives FDA approval for qualitative anti-HCV immunoassay test |
May 26. 2010
Genzyme receives FDA approval for Lumizyme for Pompe disease |
May 25. 2010
Genzyme announces final terms of FDA consent decree |
May 25. 2010
Novartis announces extension of US regulatory priority review period for FTY720, an investigational once-daily oral multiple sclerosis therapy |
May 25. 2010
Abbott receives FDA clearance for new, easier-to-use FreeStyle Lite test strips |
May 20. 2010
FDA to disclose more details on drug, food safety |
May 11. 2010
FDA asked to restrict drug marketers' use of social media |
May 10. 2010
"cGMP" for Jungbunzlauer Ladenburg |
May 10. 2010
Legacy Pharmaceuticals announces FDA approval of new packing line |
May 10. 2010
Bayer receives approval for its new oral contraceptive in the U.S. |
May 10. 2010
FDA accepts Novartis Vaccines' sBLA to expand indication of Menveo to children 2-10 years of age |
May 06. 2010
FDA sends warning letter to Novartis regarding websites |
May 03. 2010
Abbott receives FDA approval for CREON to include dosing information for patients with chronic pancreatitis and pancreatectomy |
April 23. 2010
Genentech submits supplemental application to FDA for Herceptin in advanced HER2-positive stomach cancer |
April 22. 2010
Novartis receives US FDA approval for Zortress (everolimus) to prevent organ rejection in adult kidney transplant recipients |
April 19. 2010
U.S. objects to Glaxo, Novartis drug promotions |
April 14. 2010
FDA maintains essential use status of Combivent Inhalation Aerosol through 2013 |
April 08. 2010
Roche NimbleGen commits to GMP and FDA submission for microarrays |
April 06. 2010
Correction - Roche Diagnostics, Inc. |
April 01. 2010
Abbott submits test to aid in identifying patients at risk of developing kidney injury |
