Search Results for “FDA” – Page 71 – media

Bayer’s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease

The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% reduction in the combined risk of stroke, cardiovascular death and heart attack / The application for marketing approval is based on the COMPASS study
- Source: press.bayer
- 606
- December 15, 2017
Bayer CAD/PAD Company Insight Janssen rivaroxaban
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

The U.S. Food and Drug Administration(FDA) expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA.
- Source: Prnewswire;
- 485
- December 14, 2017
EGPA New Approvals vasculitis
FDA suggests controls on interoperable devices

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
- Source: massdevice
- 562
- December 14, 2017
FDA interoperable medical device Policy
FDA Approves Admelog, the First Short-acting “Follow-on” Insulin Product to Treat Diabetes

The U.S. Food and Drug Administration(FDA) approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway).
- Source: fda.gov
- 596
- December 13, 2017
Admelog blood sugar diabetes New Approvals
Streamlined CFDA Review Process — New Opportunities in China

The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
- Source: brandwoodbiomedical
- 634
- December 8, 2017
CFDA China medical device
FDA Announces 3 New Digital Health Policy Changes

FDA Commissioner Scott Gottlieb, MD, today announced 3 policy changes meant to encourage digital health innovation while modernizing the agency’s oversight of new tech.
- Source: hcanews
- 1,263
- December 8, 2017
digital health FDA innovation Policy
FDA Grants Genentech’s Avastin Full Approval for Most Aggressive Form of Brain Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA's accelerated approval program.
- Source: Gene
- 555
- December 8, 2017
FDA Genentech New Approvals Roche
First Video Game Therapy Heads to FDA As Akili Touts ADHD Study Win

For the first time ever, a mobile video game used to assess and treat a disease is headed for an FDA review.
- Source: xconomy
- 481
- December 7, 2017
ADHD Attention Performance Index Company Insight video game
Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for OZEMPIC® (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1 OZEMPIC® is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.
- Source: medicalxpress
- 568
- December 6, 2017
diabetes FDA Novo Nordisk OZEMPIC®
FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The US Food and Drug Administration (FDA) today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the US for the treatment of cancer.
- Source: mdlinx
- 624
- December 5, 2017
breast cancer FDA herceptin New Approvals Ogivri stomach cancer

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