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 The leading web portal for pharmacy resources, news, education and careers July 4, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 4, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 34     Next >>     Go To Page:

7/3/15 - Breathe Technologies, Inc. Announces FDA Clearance for Life2000 Ventilation System
By a News Reporter-Staff News Editor at Health& Medicine Week Breathe Technologies, Inc., a developer and manufacturer of medical technologies for patients with respiratory insufficiency and neuromuscular diseases, announced that the U.S. Food and Drug Administration has granted 510 clearance for its critical care Breathe Technologies Life2000...
7/3/15 - Ortho-Clinical Diagnostics, Inc. Receives FDA 510k Clearance for VITROS Chemistry Products HbA1c Reagent Kit, an Enhanced Diabetes Testing Assay
By a News Reporter-Staff News Editor at Health& Medicine Week Ortho-Clinical Diagnostics, Inc. announced that the U.S. Food and Drug Administration has cleared the VITROS Chemistry Products HbA1c Reagent Kit to be used on the VITROS 5600 Integrated System, VITROS 4600 Chemistry System, and the VITROS 5,1 FS Chemistry System. The test
7/3/15 - Vertex drug gets FDA approval [Boston Herald]
July 03 The Food and Drug Administration yesterday approved Vertex Pharmaceuticals' latest cystic fibrosis drug, offering new hope for about 8,500 of the 30,000 Americans who suffer from the life-threatening genetic disease. "I was driving home from work when the news popped up on my phone, and I started bawling; I called my dad and said,' Thank
7/2/15 - Adapt Pharma Acquires Narcan NDA and Obtains License to the Narcan Trademark
Adapt Pharma Limited announced today that it has obtained a license to the Narcan trademark and acquired the related Narcan New Drug Application. Adapt Pharma previously announced that it had commenced a rolling submission of an NDA to the FDA for a nasal spray formulation of naloxone, a drug intended to treat opioid overdose. Use of the Narcan nam
7/2/15 - ADDING MULTIMEDIA FDA Approves ORKAMBI? (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration approved ORKAMBI?, the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two
7/2/15 - FDA approves new combination pill for cystic fibrosis from Vertex Pharmaceuticals
WASHINGTON 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.
7/2/15 - FDA Approves ORKAMBI? (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration approved ORKAMBI?, the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two
7/2/15 - FDA Approves Vertex's Cystic Fibrosis Drug Orkambi
CAMBRIDGE- Vertex Pharmaceuticals Inc. said Thursday that the U.S. Food and Drug Administration has approved Orkambi, the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. Of the 30,000 people in the United States with cystic fibrosis, about 8,500 ages 12 and older h
7/2/15 - FDA clears drug for leading form of cystic fibrosis
But it will come at a steep price more than $250,000 for a year's treatment. The Food and Drug Administration cleared the twice-a-day pill from Vertex Pharmaceuticals Inc. for a variation of cystic fibrosis that affects about 8,500 people in the U.S. who are 12 years and older. Vertex said Orkambi will cost $259,000 per year.
7/2/15 - First Medical Device Cleared by FDA With Adherence Claim
Proteus Digital Health, Inc. today announced that the FDA has expanded the Indications for Use statement for the latest generation of its Ingestible Sensor technology, enabling the device to be used as an aid in the measurement of medication adherence. To the Company s knowledge, this is the only device with an FDA- sanctioned claim for measurin
7/2/15 - Luye Pharma's product candidate approved for clinical trials [ET Net News (China)]
Luye Pharma said its product candidate,. ansofaxine hydrochloride extended release tablets, a Class 1.1 New Chemical. Drug, has obtained the approval from the China Food and Drug Administration to.
7/2/15 - Spriaso Announces Approval of New Drug Application for the Long Acting Codeine Antitussive With a Popular Anti-Histamine [National News Agency (Lebanon)]
-Spriaso LLC., today announced FDA approval of a New Drug Application for Tuxarin ER , a unique high strength long acting Rx cough/cold combination product containing codeine and chlorpheniramine. Tuxarin ER , co-developed with Nexgen Pharma, will be the first product to offer long lasting cough suppression with a safer opiate that is less pron
7/2/15 - Theranos Receives First FDA Clearance for Finger Stick and Venous Blood Test and Independent FDA Review and Validation of its Underlying Theranos System for Herpes Simplex Virus-1 Diagnosis
Theranos, Inc. today announced that it has received the U.S. Today s announcement demonstrates that Theranos has met that standard and is an important step in Theranos mission to make health information accessible to people at the time it matters, enabling early detection and prevention of disease, and empowering individuals everywhere with i
7/1/15 - Breathe Technologies, Inc. Announces FDA Clearance for Life2000 Ventilation System
By a News Reporter-Staff News Editor at Journal of Engineering Breathe Technologies, Inc., a developer and manufacturer of medical technologies for patients with respiratory insufficiency and neuromuscular diseases, announced that the U.S. Food and Drug Administration has granted 510 clearance for its critical care Breathe Technologies Life2000..
7/1/15 - Spriaso Announces Approval of New Drug Application for the Long Acting Codeine Antitussive With a Popular Anti-Histamine
Spriaso LLC., today announced FDA approval of a New Drug Application for Tuxarin ER , a unique high strength long acting Rx cough/cold combination product containing codeine and chlorpheniramine. Tuxarin ER , co-developed with Nexgen Pharma, will be the first product to offer long lasting cough suppression with a safer opiate that is less pro
7/1/15 - TCM cancer treatment enters final trials in US [China Daily: Hong Kong Edition]
The drug, known as Kanglaite Injection, contains anticancer compounds extracted from the seed of coix, a grasslike relative of maize, and has been approved and used as a cancer treatment in China since 1995.. Its inventor, Li Dapeng, has been seeking registration for the drug in the United States. The US Food and Drug Administration gave the go-ahe
7/1/15 - U.S. FDA Approves Alternate Confirmation Test for Essure Permanent Birth Control
Bayer HealthCare announced today that the U.S. Food and Drug Administration has approved the use of transvaginal ultrasound as an alternate confirmation test for Essure permanent birth control. Originally approved by the FDA in 2002, Essure is a non-hormonal permanent birth control option with a non-surgical procedure. With this FDA approval,
6/30/15 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug Administration Regulated Products. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled, "Export Certificates for FDA Regulated Products" has been approved by the Offi
6/30/15 - Breathe Technologies, Inc. Announces FDA Clearance for Life2000 Ventilation System
By a News Reporter-Staff News Editor at Journal of Technology Breathe Technologies, Inc., a developer and manufacturer of medical technologies for patients with respiratory insufficiency and neuromuscular diseases, announced that the U.S. Food and Drug Administration has granted 510 clearance for its critical care Breathe Technologies Life2000...
6/30/15 - GORE EXCLUDER Conformable AAA Endoprosthesis Receives Approval for Clinical Study in the US and Japan
By a News Reporter-Staff News Editor at China Weekly News W. L. Gore& Associates, Inc. announced that the Food and Drug Administration has consented to the initiation of the clinical study for the new GORE EXCLUDER Conformable AAA Endoprosthesis and the Japanese clinical trial notification for the new device was accepted by Japan's Pharmace
6/30/15 - Maryland Practice Among First to Offer New Treatment for Double Chin
Noted dermatology practice Maryland Laser Skin and Vein is the first practice in Maryland and one of the first practices on the east coast to offer Kythera's brand-new non-invasive double chin treatment Kybella. Kybella received U.S. Food and Drug Administration approval in April for the reduction of submental fat under the chin, and Maryland Laser
6/30/15 - Proteros Appoints Dr. Torsten Hoffmann as Chief Scientific Officer [Global Data Point]
Before joining Proteros, Dr. Hoffmann was Chief Scientific Officer at Denmark- based Zealand Pharma A/S and Head of Discovery Chemistry at Roche in Basel. He is inventor of an anti-emetic medicine which received FDA approval as Akynzeo in 2014. Under his leadership at Roche more than 20 new chemical entities entered into clinical trials and 52 n
6/30/15 - SentreHEART Secures FDA Approval for the AMAZE Trial [Health & Beauty Close - Up]
SentreHEART reported that it has received approval for an Investigational Device Exemption from the U.S. Food and Drug Administration to begin enrollment in a clinical study of the LARIAT Suture Delivery Device. "The LAA is an important site for atrial fibrillation initiation and persistence, and its exclusion using the LARIAT device as an adjunct
6/30/15 - Ventana receives FDA approval for the first fully automated IHC companion diagnostic to identify lung cancer patients eligible for XALKORI crizotinib
By a News Reporter-Staff News Editor at Cancer Weekly Ventana Medical Systems, Inc., a member of the Roche Group, announced approval of the VENTANA ALK CDx Assay by the US Food and Drug Administration as a companion diagnostic to aid in the identification of patients for Pfizer's FDA approved targeted therapy, XALKORI. "The test provides physici
6/29/15 - Advanced Cooling Therapy Gets FDA De Novo Clearance for Esophageal Cooling Device to Cool and Warm Patients [Health & Beauty Close - Up]
Emerging medical device firm Advanced Cooling Therapy has received a de novo clearance from the US Food and Drug Administration to market its first product, the Esophageal Cooling Device, in the United States. It received its CE Mark in Europe in 2014, is licensed for sale in Canada and Australia, and will be available to medical professionals in t
Articles(s): 1 - 25 of 34     Next >>     Go To Page:


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