FDA – Page 16 – media

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
- 519
- 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
- 558
- 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
- 476
- 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
- 595
- 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
- 744
- 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
- 496
- 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
- 632
- November 17, 2017
FDA Hemlibra inhibitor pediatric
FDA Clears First Device to Help Curb Opioid Cravings

The US Food and Drug Administration (FDA) has approved a device designed to reduce the symptoms of opioid withdrawal.
- Source: medscape
- 574
- November 16, 2017
cranial nerves FDA New Approvals opioid stimulator
Real-World Study Confirms Lower Brain Bleed Risk with Dabigatran

Real-world outcomes among patients with atrial fibrillation taking the anticoagulant dabigatran (Pradaxa) mimic those reported in clinical trials, with dabigatran use associated with lower rates of brain bleeds, and similar rates of stroke and extracranial hemorrhage as treatment with warfarin in a new study.
- Source: medpagetoday
- 565
- November 14, 2017
atrial fibrillation dabigatran FDA Pradaxa Researches
Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) for Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) and CD30-Expressing Mycosis Fungoides (MF)

Seattle Genetics, Inc. (SGEN) announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Primary cutaneous ALCL and MF are the most common subtypes of cutaneous T-cell lymphoma (CTCL).
- Source: finance.yahoo
- 470
- November 13, 2017
ADCETRIS anaplastic large cell lymphoma FDA

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