Noctrix Health aims to treat RLS symptoms with its wearable neuromodulation platform that targets specific peripheral nerve fibers in a manner that is comfortable to wear to sleep.
Merck has received approval from the U.S. Food and Drug Administration (FDA) for an update to the...
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...
Vanda 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...
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.
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Sleep Review’s annual roundup of the devices, pharmaceuticals, and more that recently earned...
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...
Read MoreOn March 30, 2018, this statement from FDA Commissioner Scott Gottlieb, MD, on FDA’s efforts to enhance the patient perspective and experience in drug development and review was released: Benefit-risk assessment is at the heart...
Read MoreKimverlee Aderhold and Eric E. Ramey, Jr., have been arraigned on federal charges of unlawfully selling stolen medical devices that require a prescription without an actual prescription. Aderhold and Ramey were indicted by a...
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