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Panther Orthopedics, Inc. Receives FDA 510(k) Clearance for the PUMA System(TM) - An Orthopedic Flex prnasia
March 08, 2018
Panther Orthopaedics, Inc., a medical device company based in San Jose, Calif., announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration.
FDA Approves 23andMe’s Direct-to-Consumer Genetic Test for Cancer biospace
March 08, 2018
The U.S. Food and Drug Administration (FDA) approved the first-ever direct-to-consumer genetic test for cancer risk.
FDA Greenlights New Treatment for Multi-Drug Resistant HIV-1 biospace
March 08, 2018
Shares of Theratechnologies Inc. and TaiMed Biologics jumped Tuesday afterFDAAdministration green lit Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the B biospace
March 07, 2018
The U.S. Food and Drug Administration today authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants)
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the worl biospace
March 07, 2018
The U.S. Food and Drug Administration today expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects.
FDA Approves 23andMe’s Direct-to-Consumer Genetic Test for Cancer biospace
March 07, 2018
The U.S. Food and Drug Administration (FDA) approved the first-ever direct-to-consumer genetic test for cancer risk
FDA Grants Sunovion’s Latuda Expanded Approval for Bipolar Depression in Pediatric Patients biospace
March 07, 2018
There is a newly approved treatment for pediatric patients with major depressing episodes associated with bipolar disorder.
FDA finds major manufacturing issues at key Aurobindo facility pharmafile
March 06, 2018
Indian pharmaceutical company Aurobindo was screened by the USFDA and the review identified nine major problems with its unit 4 in Hyderabad, India
FDA to review Sanofi’s Dupixent in asthma pharmaphorum
March 06, 2018
The FDA is to review Sanofi/Regeneron’s Dupixent as a treatment for asthma, a new use that could more than double its sales following its previous approval for eczema.
Corindus Receives FDA Clearance for First Automated Robotic Movement in technIQ™ Series for CorPath biospace
March 06, 2018
Corindus Vascular Robotics Inc. announced today that it received 510(k) clearance from the FDA for the first automated robotic movement designed for the CorPath GRX platform.

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