WASHINGTON- Shares of Incyte Corp. have gained nearly 38% year-to-date compared to a modest 8.77% rise in the iShares NASDAQ Biotech Index ETF during the same period. The Company received its first FDA approval in November 2011 and it was for Jakafi, a JAK1 and JAK2 inhibitor, indicated for the treatment of patients with myelofibrosis and polycythe
By a News Reporter-Staff News Editor at Drug Week- iCAD, an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, announced that PowerLook Tomo Detection received Premarket Approval from the U.S. Food and Drug Administration. "As the use of 3 D mamm
Extensive R&D activities initiated by various major players has led to development of various advancements in precision medicine that have received FDA approval. For instance, in 2015, the U.S. government launched the Precision Medicine Initiative, under which a grant of approximately US$ 215 million was sanctioned for the Precision Medical Initiat
The U.S. Food and Drug Administration has given the thumbs up to a genetically modified chicken that produces a drug in its eggs. Kanuma, a recombinant human enzyme marketed by Alexion Pharmaceuticals, replaces the faulty enzyme responsible for the disorder, which is often fatal in infants. LAL deficiency is a rare inherited genetic disorder that c
Shares of Neurocrine Biosciences leaped more than 22 percent Wednesday after the biotech firm announced federal approval of its drug for a movement disorder. Neurocrine announced late Tuesday that the Food and Drug Administration has approved Ingrezza, the only product for treatment of adults with tardive dyskinesia, or TD. Christoph U. Correll, pr
Advanced Cooling Therapy has received 510 clearance from the US Food and Drug Administration for use of its Esophageal Cooling Device with the Altrix Precision Temperature Management System by Stryker . ACT s ECD received US FDA de novo clearance in June of 2015 for use with the Medi-Therm III by Stryker and received FDA 510 clearance in Ja
Madison, Wisconsin- based EnsoData has received FDA clearance for its sleep analysis software called EnsoSleep, which uses machine learning to analyze sleep quality and aide in diagnosis of sleep or respiratory-related sleep disorders. FDA clearance of the EnsoSleep technology represents an historic milestone for our company and sleep clinicians wh
-Entellus Medical, Inc., a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced the Company has received 510 clearance from the United States Food and Drug Administration for use of its..
By a News Reporter-Staff News Editor at Women's Health Weekly- TESARO, Inc., an oncology-focused biopharmaceutical company, announced that the U.S. Food and Drug Administration has approved ZEJULA?, an oral, once-daily poly polymerase inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary
United Orthopedic Corporation, a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration cleared its E-XPE polyethylene knee insert. The knee insert is designed to provide patients with knee replacements with reduced risk of oxidation.
Entellus Medical, Inc., a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced the Company has received 510 clearance from the United States Food and Drug Administration for use of its.
ENTELLUS MEDICAL, INC. (NASDAQ:ENTL) Files An 8-K Other Events Item8.01. Other Events. On April12, 2017, Entellus Medical, Inc. (the Company) announced the Company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use of its XprESS ENT Dilation System in patients with persistent Eustachian tube dysfunction.
The New Drug Application pre-submission meeting with the FDA took place on March 14, 2017, during which the Company shared preliminary data from SECURE, a phase III trial of Twirla that was conducted to address issues raised by the FDA in its 2013 Complete Response Letter to the Company. Twirla was turned down by the FDA in 2013.. Based on the feed
The US Food and Drug Administration, which is responsible for evaluating the safety and efficacy of medicines in the United States, has approved Sovaldi and Harvoni for the treatment of hepatitis C in adolescents aged 1217 years. The drugs are the first direct-acting antiviral treatments to be approved for treating this age group. These approvals w
Release date- 11042017- The U.S. Food and Drug Administration today approved Ingrezza capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition. 'Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,' said Mitchell Mathis, M.D., director of the Division of
April 12 Globes correspondent Israeli surgical guidance systems developer Mazor Robotics Ltd. (Nasdaq: Mazor Robotics Ltd. has received FDA clearance for its Mazor X Align? software. Mazor X Align leverages Mazor Robotics' extensive experience in pre-operative planning, image processing, computerized anatomy recognition, and registration of dif
The FDA has cleared the SOMATOM go. CT platform from Siemens Healthineers. Created with extensive customer feedback, the new platform includes the SOMATOM go.Now and SOMATOM go.Up CT scanners, which offer automated, standardized workflows designed to help users achieve more consistent clinical results.
Mazor Robotics Ltd., a pioneer and leader in the field of surgical guidance systems, has received FDA clearance for its Mazor X Align? software. The new software will be demonstrated during exhibit hours at the 2017 American Association of Neurological Surgeons Annual Scientific Meeting in Los Angeles, CA, April 22-26. According to Ori Hadomi, CE
Neodyne Biosciences, Inc. today announced the launch of its first national advertising campaign for embrace Active Scar Defense, the only FDA cleared scar therapy system designed to relieve tension surrounding incisions, general cuts and lacerations to prevent scarring before it begins. Neodyne has plans to expand the availability of embrace
"It's an urban myth" that the FDA is slower than other countries to clear promising treatments for patients, said the agency's longtime cancer drugs chief, Dr. The new research compared how new drugs fared before the FDA and the European Medicines Agency between 2011 and 2015. The FDA approved more drugs than the Europeans- 170 versus 144- with a m
United Orthopedic Corporation, a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration cleared its E-XPE? polyethylene knee insert. "Clearance of our E-XPE? polyethylene knee insert represents an important milestone in our kne
Ventec Life Systems, an innovator in integrated respiratory care solutions, announced today it received 510 clearance from the U.S. Food and Drug Administration for VOCSN, the only portable life support device to combine five respiratory therapies- Ventilation, Oxygen, Cough, Suction, and Nebulization. This Smart News Release features multimedia.
Alere Inc., a global leader in rapid diagnostics, today announced that its Alere? Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, has received 510 marketing clearance from the US Food and Drug Administration. This reformulated test card is the first rapid antigen influenza test to achieve 510 cleara
ArQule, Inc. today announced that it has received clearance from the U.S. Food and Drug Administration for the Investigational New Drug application to conduct a phase 1 clinical trial with ARQ 531 in patients with B-cell malignancies who are refractory to other therapeutic options. The Registrant's press release dated April 11, 2017, a copy of whic