HETLIOZ (tasimelteon) improved sleep quality and increased sleep duration in patients with Smith-Magenis Syndrome in a placebo-controlled clinical study.
CPAPNEA Medical Supply has a cleared 510(k) for the Optipillows EPAP mask for the sole intended use of alleviating snoring during sleep in adults, states the FDA in a warning letter.Your device is misbranded under section...
![FDA Preliminary Lab Tests: Several CPAP Cleaners Generate Ambient Levels of Ozone Above Safe Limits [Video]](https://www.sleepreviewmag.com/wp-content/uploads/2020/03/ozone-cpap-cleaners-150x150.jpg)
Mylan NV on June 1 announced the US launch of Armodafinil tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon’s Nuvigil. Mylan received final approval from the Food and Drug Administration (FDA) for its...
The US Food and Drug Administration (FDA) issued a notice requesting nominations for voting...
Read MoreVanda Pharmaceuticals Inc received a complete response letter (CRL) from the US Food and Drug Administration (FDA) on Aug 16 as part of the FDA’s ongoing review of Vanda’s supplemental New Drug Application...
Read MoreVanda Pharmaceuticals Inc received a notification from the US Food and Drug Administration (FDA) on July 19 stating that as part of its ongoing review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ...
Read MoreXW Laboratories Inc, a China-based clinical-stage biopharmaceutical company pioneering the discovery of novel small molecule therapeutics for the treatment of neurological disorders, has received the U.S. Food and Drug...
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Healthcare innovation startup NightWare Inc, a privately-held digital therapeutics for mental...
Read MoreTo see light as a prescription digital therapeutic for PTSD patients affected by nightmares, NightWare is testing its app among veterans and the general public, reports MobiHealthNews. “[Breakthrough status] is a really nice...
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The US Food and Drug Administration (FDA) today announced the agency is requiring a new boxed...
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After six years on the market, Zyppah has been granted US Food and Drug Administration (FDA)...
Read MoreThe US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. A Prescription Drug...
Read MoreThe FDA recently issued a final order to reclassify auto titration devices for oral appliances to Class II devices.
Read MoreVanda Pharmaceuticals Inc announced that a HETLIOZ patent, number 10,071,977 (‘977 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence...
Read MoreThe FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The following recall has been posted on FDA.gov. Recalled Product(s): Replacement...
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FDA Commissioner Scott Gottlieb, MD, says requiring a cancer warning on coffee, based on the presence of acrylamide, would be more likely to mislead consumers than to inform them.
Read MoreFDA Commissioner Scott Gottlieb, MD, made the following statement on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation. Advances in material science, digital technology and advanced...
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On April 13, the US Food and Drug Administration (FDA) took a step to better protect consumers...
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