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SAN JOSE, Calif., Feb. 10, 2021 /PRNewswire/ Visby Medical™ announced today the US Food and Drug Administration (FDA) authorized Visby s rapid PCR COVID-19 test for use at the point of care (POC). Building on the FDA s emergency use authorization granted earlier this year, Visby Medical s rapid PCR COVID-19 test may now be used by any organization with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver.
Visby Medical Test - Now Authorized for CLIA-Waived Settings
It is imperative that the best tools are available to fight infection, protect the most vulnerable and maintain essential operations. PCR testing has been acknowledged as the gold standard for its high level of accuracy, but has drawbacks including the reliance on centralized labs and long wait times for results.
Published: Feb 01, 2021
FINTEPLA offers a new treatment option for patients in Germany with Dravet syndrome, a rare, devastating, infant-onset epilepsy marked by frequent seizures, medical emergencies, and developmental impairments
FINTEPLA was approved by the European Commission in December 2020 based on data from two Phase 3 studies demonstrating it safely and significantly reduced convulsive seizure frequency for Dravet syndrome patients whose seizures were not adequately controlled on their existing medications
EMERYVILLE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE)
Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, announced today that FINTEPLA
® (fenfluramine) oral solution is now available in Germany for the treatment of seizures associated with Dravet syndrome in patients aged two years and older, as an add-on therapy to existing anti-epileptic medications. Dravet syndrome is a rare, lifelong epilepsy that begins in infancy