Search Results for “FDA” – Page 72 – media

FDA Clears First Medical Device Accessory for Apple Watch®

Atrial Fibrillation (AFib), is the most common heart arrhythmia, and a leading cause of stroke. AFib affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it. Millions of people around the world are unknowingly living with AFib. Yet, two out of three strokes are preventable when AFib is detected and treated appropriately.
- Source: Prnewswire
- 536
- December 4, 2017
AI Apple Watch New Approvals
Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority

Review Designation of Mogamulizumab’s Biologics License Application
- Source: drugdu
- 477
- November 29, 2017
Biologics License Application FDA New Approvals
Allegoric Receives FDA Approval For Use of VRAYLAR™ (cariprazine) in the Maintenance Treatment of Schizophrenia

Allergan plc (NYSE: AGN) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VRAYLAR™ (cariprazine) for the maintenance treatment of adults with schizophrenia. VRAYLAR is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.
- Source: Allergan
- 469
- November 24, 2017
bipolar I disorder FDA schizophrenia VRAYLAR™
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients

The U.S. Food and Drug Administration(FDA) today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens' power after cataract surgery so that the patient will have better vision when not using glasses.
- Source: Prnewswire
- 512
- November 23, 2017
cataract FDA Light Adjustable Lens Light Delivery Device medical device
US FDA grants Breakthrough Therapy Designation for Roche’s Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC

The latest BTD was granted for the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.
- Source: Roche
- 554
- November 23, 2017
anaplastic lymphoma kinase Company Insight FDA non-small cell lung cancer Roche
FDA approves first two-drug regimen for certain patients with HIV

The U.S. Food and Drug Administration(FDA) today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.
- Source: finance.yahoo
- 469
- November 22, 2017
FDA HIV immunodeficiency Juluca New Approvals
FDA OKs Genentech’s Gazyva for Untreated Follicular Lymphoma

Twice on Thursday, Genentech, scored two approvals from the U.S. Food and Drug Administration(FDA) – a new medicine for hemophilia and an expansion for its cancer drug Gazyva.
- Source: Biospace
- 589
- November 21, 2017
cancer FDA hemophilia lymphoma New Approvals
FDA approves new treatment Hemlibra (emicizumab-kxwh) to prevent bleeding in certain patients with hemophilia A

The U.S. Food and Drug Administration(FDA) approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
- Source: pharmacist
- 738
- November 20, 2017
FDA Hemlibra hemophilia inhibitor New Approvals
Pfizer Receives FDA Approval for SUTENT® (sunitinib malate) as First and Only Adjuvant Treatment for Adult Patients

Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration(FDA) has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). The approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received SUTENT compared to placebo in the adjuvant setting.
- Source: finance.yahoo
- 490
- November 20, 2017
DFS FDA nephrectomy RCC SUTENT
FDA approves new drug to treat bleeding in hemophilia A patients

The U.S. Food and Drug Administration(FDA) today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
- Source: news-medical
- 625
- November 17, 2017
FDA Hemlibra inhibitor pediatric

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