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Tag: fda
FDA approves new combination pill for cystic fibrosis from Vertex Pharmaceuticals
2015-07-02 19:21:57| Biotech - Topix.net
Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. The Food and Drug Administration cleared the twice-a-day pill from Vertex Pharmaceuticals for a variation of cystic fibrosis that affects about 8,500 people in the U.S. who are 12 years and older.
Tags: combination
pill
pharmaceuticals
fda
FDA OKs second test to see if Essure contraceptive is placed right
2015-07-01 19:56:33| Chemicals - Topix.net
Bayer Healthcare said on Wednesday the U.S. Food and Drug Administration approved using transvaginal ultrasound as an alternate test to confirm if the company's Essure permanent birth control device has been placed properly. Essure is a small metal coil inserted into woman's fallopian tubes.
MM-398 Receiving The Priority Review Designation By US FDA For New Drug Application And The Acceptance Of Market Authorization Application By EMA In Post-Gemcitabine Metastatic Pancreatic Cancer
2015-07-01 08:52:42| drugdiscoveryonline Home Page
PharmaEngine, Inc. (TWO: 4162) announced that (1) its license partner, Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK), has received the notification from the US Food and Drug Administration (FDA) for the acceptance and the grant of the priority review designation for their New Drug Application (NDA); and (2) its sublicense partner, Baxalta Incorporated, a wholly owned subsidiary of Baxter International Inc. (NYSE: BAX) has received the acceptance of Market Authorization Application (MAA) from the European Medicines Agency (EMA), of MM-398 (irinotecan liposome injection, also known as "nal-IRI,") in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy
Tags: review
market
application
drug
Sarepta Therapeutics Completes NDA Submission To FDA For Eteplirsen For The Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping
2015-07-01 08:07:56| drugdiscoveryonline Home Page
Sarepta Therapeutics, Inc., a developer of innovative RNA-targeted therapeutics, recently announced the completion of the rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for eteplirsen on June 26, 2015
Tags: to
treatment
submission
fda
FDA Approval Pumps New Life Into Edwards Stock
2015-06-27 09:00:47| Biotech - Topix.net
With FDA approval for its new Sapien 3 artificial heart valve, Edwards Lifesciences is nearing a new buy point in a first-stage base. The maker of products to treat advanced cardiovascular disorders may also get a boost from the positive impact the Supreme Court's ObamaCare decision is having on medical and health care stocks.
Tags: life
stock
approval
edwards
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