New Approvals – Page 10 – media

FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. While the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
- Source: prnewswire
- 691
- April 25, 2018
baricitinib Eli Lilly New Approvals RA
mHealth App Aims to Help Caregivers Identify Perinatal Depression

The mHealth app, designed by researchers at the Worcester Polytechnic Institute, helps obstetric care providers identify perinatal depression in soon-to-be and new mothers and gives them care management tips.
- Source: mHealth Intelligence
- 655
- April 24, 2018
mHealth New Approvals pregnancy
Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita® (burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH)

First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease
- Source: globenewswire
- 961
- April 19, 2018
biopharmaceutical FDA New Approvals rare and ultra-rare diseases
Shire——FDA approves VONVENDI® for perioperative management of bleeding in adult patients with von Willebrand disease

Cambridge, Ma. -- Shire plc, the global biotechnology leader in rare disease, today announced the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (recombinant)], a recombinant von Willebrand factor (rVWF) treatment for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD).
- Source: 4-traders;
- 602
- April 19, 2018
New Approvals rVWF VONVENDI VWD
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment

Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
- Source: news.bms
- 910
- April 17, 2018
New Approvals Opdivo RCC Yervoy
Brentuximab Vedotin Approved for Classical HL

The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
- Source: cancernetwork
- 668
- April 16, 2018
ADCETRIS cHL New Approvals
ARKAY Therapeutics Submits Investigational New Drug (IND) Application for RK-01, a First-in Class ‘Beta-cell-centric’ Drug Combination Product for Type 2 Diabetes

First Human Proof-of-Concept (PoC) Trial to Test the Superiority of RK-01 over Metformin in Type 2 Diabetes Patients with Inadequate Glycemic Control.
- Source: Pipelinereview
- 525
- April 13, 2018
New Approvals type 2 diabetes
FDA approves first AI-powered device to detect diabetic retinopathy

The FDA today approved the first medical device to harness artificial intelligence for the detection of diabetic retinopathy in adults who have diabetes.
- Source: Drug Delivery Business News
- 682
- April 13, 2018
AI FDA New Approvals
FDA Prolongs Review Date for AbbVie Endometriosis Candidate

The FDA extends the review period of NDA for AbbVie (ABBV) and partner Neurocrine Biosciences' endometriosis candidate, elagolix, by three months to third-quarter 2018.
- Source: finance.yahoo
- 548
- April 12, 2018
elagolix endometriosis New Approvals
Novartis’ Afinitor Disperz wins new TSC-related approval

Novartis’ Afinitor Disperz has become the first medicine to be specifically approved by US regulators to treat patients aged two years and above with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
- Source: pharmatimes
- 741
- April 12, 2018
Afinitor Disperz New Approvals Novartis TSC

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