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Tag: fda
FDA OKs breakthrough cholesterol drug for high-risk patients
2015-07-24 21:19:33| Biotech - Topix.net
" The Food and Drug Administration says it has approved a first-of-a-kind drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades. The drug from Sanofi and Regeneron Pharmaceuticals Inc. offers an important new option for millions of patients at high risk of heart disease.
Tags: drug
patients
cholesterol
breakthrough
FDA Clears MiraDry for Underarm Hair Reduction
2015-07-24 07:00:00| Happi Breaking News
Treatment also delivers permanent reduction of sweat.
Tags: hair
reduction
fda
clears
Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis
2015-07-23 21:20:21| Biotech - Topix.net
Amgen today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy.
Tags: application
drug
submission
announces
FDA announces detail of Essure meeting
2015-07-23 05:15:30| Chemicals - Topix.net
The Food and Drug Administration announced details Wednesday for the upcoming public meeting that will be held regarding Essure permanent birth control. The meeting will be held on September 24, 2015 from 8 a.m. until 6 p.m. in front of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, which reviews the safety and effectiveness of marketed devices.
Tags: detail
meeting
announces
fda
Bristol-Myers says HIV drug gets FDA incentives
2015-07-21 20:30:52| Biotech - Topix.net
The Food and Drug Administration designated the drug BMS-663068 as a breakthrough treatment, so Bristol-Myers Squibb Co. will get extra meetings with the FDA and earlier communication with scientists as it studies the drug.
Tags: drug
hiv
incentives
fda
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