New Approvals – Page 12 – media

Device able to quickly and accurately detect stroke

A new visor-like device worn by patients can help providers and emergency medical personnel detect a stroke that requires comprehensive care within seconds and with greater than 90 percent accuracy.
- Source: Health Data Management
- 736
- April 3, 2018
FDA medical device New Approvals stroke
EMA to review sotagliflozin as potential treatment for type 1 diabetes

The European Medicines Agency (EMA) has accepted for review Sanofi’s regulatory submission for sotagliflozin. If approved, the oral treatment would be used as an addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes mellitus.
- Source: mediaroom.sanofi
- 580
- April 2, 2018
diabetes New Approvals sotagliflozin
Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound.
- Source: Shire
- 617
- April 2, 2018
angioedema HAE lanadelumab New Approvals
FDA clears Medtronic’s smartphone-connected CGM for MDI users

Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016.
- Source: mobihealthnews
- 823
- March 30, 2018
FDA Guardian Connect insulin Medtronic New Approvals
Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
- Source: finance.yahoo
- 548
- March 29, 2018
HIV-1 New Approvals Symfi™
Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
- Source: Novartis
- 639
- March 29, 2018
FDA New Approvals Ph+ CML-CP Tasigna®
U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review

Bristol-Myers Squibb Company (BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.
- Source: drugdu
- 596
- March 29, 2018
FDA MBS New Approvals Opdivo
FDA clears new Dexcom CGM that requires no patient calibration earlier than expected

Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
- Source: MedCityNews
- 718
- March 29, 2018
diabetes FDA insulin New Approvals
Amgen And Allergan Receive Positive CHMP Opinion For ABP 980 (Biosimilar Herceptin®) For The Treatment Of Three Types Of Cancer

Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
- Source: finance.yahoo
- 618
- March 28, 2018
Allergan Amgen biosimilar herceptin New Approvals
Bayer announces completion of rolling submission of New Drug Application in the U.S. for larotrectinib for the treatment of TRK fusion cancer

Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company based in Stamford, Connecticut (US), has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
- Source: investor.bayer.de
- 596
- March 28, 2018
FDA larotrectinib New Approvals NTRK

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