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Category: FDA

Press releases and articles
September 07. 2010
Sandoz receives FDA approval for another new indication for Omnitrope and launches Patient Assistance Program
August 27. 2010
Genentech provides update on FDA application for T-DM1
August 26. 2010
FDA requires label changes for flu vaccines to highlight latex concerns
August 25. 2010
FDA warns Johnson & Johnson over two products
August 24. 2010
Sanofi-Aventis sues FDA to stop generic blood-thinner drug
August 23. 2010
FDA conducting safety review of Novartis drug Stalevo
August 20. 2010
Eli Lilly and Company states approval recommendation from FDA Advisory Committee for expanding the indications for Cymbalta
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 18. 2010
FDA questions wider approval of Lilly's Cymbalta
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
August 02. 2010
FDA finds problems at Sanofi vaccine plant
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 13. 2010
FDA guidance on impurities in generic drugs drives - LGC Standards’ expansion of product range
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 29. 2010
Teva announces approval of generic Effexor XR
June 29. 2010
Teva announces launch of generic ARIMIDEX
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 16. 2010
Capsugel France facility receives FDA approval
June 11. 2010
Regulators urged to help develop antibiotics
June 09. 2010
US eyes safety of Novartis' MS drug ahead of panel
June 02. 2010
Congress investigating J&J 'phantom recall'
June 01. 2010
FDA weighing penalties against J&J
June 01. 2010
FDA announces collaboration with Drugs.com
May 28. 2010
Teva will stop making anesthetic
May 28. 2010
Roche Diagnostics receives FDA approval for qualitative anti-HCV immunoassay test
May 27. 2010
Sanofi prostate cancer drug shows 28 percent survival
May 26. 2010
Teva announces launch of generic Valtrex
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