Search Results for “FDA” – Page 69 – media

3D Printing Goes Legit with FDA Guidance

The FDA guidance does give potential 3D medical device manufacturers a path to follow to prepare for FDA approval.
- Source: HealthTech Insider
- 617
- January 18, 2018
3D printing FDA medical device products Policy
GBT Receives FDA Breakthrough Therapy Designation for Voxelotor for Treatment of Sickle Cell Disease (SCD)

Global Blood Therapeutics, Inc. (GBT) (GBT) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to voxelotor (previously called GBT440) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD and previously received European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of SCD.
- Source: finance.yahoo
- 535
- January 16, 2018
FDA New Approvals SCD Voxelotor
Teva Announces U.S. FDA Approval of TRISENOX (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide
- Source: finance.yahoo
- 545
- January 16, 2018
APL arsenic trioxide FDA New Approvals Teva TRISENOX
Newly FDA-Approved Platform Will Rapidly “Manufacture” Stem Cells to Repair Our Bodies

Stem cells have the unique capability to transform into any sort of specialized cell needed in the body, making them especially promising for medicine that replaces nonfunctional or dead cells.
- Source: Futurism
- 484
- January 16, 2018
FDA New Approvals stem cells
FDA approves algorithm that predicts sudden patient deaths to help prevent them

Wave Clinical Platform is the work of ExcelMedical and is a system that monitors patients' vital signs, sending alerts that warn of potentially fatal heart attacks or respiratory failure up to six hours before a patient suffers such an event.
- Source: Digital Trends
- 502
- January 16, 2018
FDA healthcare technology New Approvals
FDA approves first treatment for breast cancer with a certain inherited genetic mutation

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.
- Source: finance.yahoo
- 545
- January 15, 2018
breast cancer Lynparza metastasized New Approvals
Eisai and Merck Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib mesylate) and KEYTRUDA® (pembrolizumab)

Eisai Co., Ltd. and Merck (MRK), known as MSD outside the United States and Canada, announced that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).
- Source: finance.yahoo
- 530
- January 11, 2018
LENVIMA New Approvals RCC
FDA Accepts New Drug Applications for Merck’s Doravirine

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults.
- Source: investors.merck
- 509
- January 11, 2018
doravirine NDAs New Approvals NNRTI
Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced that its New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Inotersen is an investigational drug for the treatment of patients with hereditary TTR amyloidosis (hATTR). Priority Review is granted by the FDA to drugs with the potential to address a serious condition and, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 6, 2018. “TTR amyloidosis is a progressive, fatal disease with very limited treatment options. Receiving Priority Review in the U.S. and Accelerated Assessment in the EU for inotersen shows that the regulatory agencies recognize the high unmet need and the urgency to identify effective therapies to treat patients with this devastating disease,” said Sarah ...
- Source: Prnewswire;
- 470
- January 10, 2018
FDA hATTR New Approvals TTR amyloidosis
FDA approves Mevion’s Hyperscan pencil beam scanning technology

Mevion S250i is a compact proton therapy system that has the capacity to deliver conformal radiation therapy treatments with the support of Hyperscan pencil beam scanning technology.
- Source: MDBR
- 539
- January 8, 2018
Company Insight FDA medical device

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