The use of plasma infusion therapies (often called "vampire" treatments) is on the rise across the United States.
Currently, the only drug approved by the Food and Drug Administration (FDA) for prophylaxis is erythromycin, a macrolide antibiotic.
The procedure, known as Elevoplasty, was investigated in the S.I.L.E.N.C.E. study (Snoring Intervention via Elevoplasty in a Non-surgical Clinical Environment) which included 52 patients.
VentStar and ID Breathing Circuits and Anesthesia Sets have been recalled because some of the devices may not have been correctly assembled, which may have resulted in a short circuited breathing hose.
Sales of electronic cigarettes could be halted if companies do not stop marketing the devices to youth.
Due to the federal government shutdown, the US Food and Drug Administration has only about 5 weeks of funding left to review new drug applications.
The pea-sized device is a self-expanding wire mesh that is inserted through an incision in the leg and guided through vessels to the heart, where it is placed to seal the opening.
The consequence of the shutdown means the budget appropriated by Congress for the Agency is on hold, resulting in approximately 7000 of it's 17,000 employees being furloughed.
In animal studies, the treatment was associated with improvement in both motor and cognitive function.
The FDA announcement came a day after the release of findings from an investigation into medical device safety worldwide.
While approved in Europe, Asia and Latin America, tianeptine is an unscheduled pharmaceutical agent in the US that has been linked to serious adverse events, including death, when used for recreational purposes.
The approval was based on data from a single-arm, open-label sequential cohort study in which patients received Promacta in combination with horse antithymocyte globulin (h-ATG) and cyclosporine.
Aemcolo is a broad spectrum, semi-synthetic, orally-administered, minimally-absorbed antibiotic designed to allow for delayed release to the colon.
The announcement comes in the wake of results from the 2018 National Youth Tobacco Survey which showed a 78% increase in current e-cigarette use among high school students from 2017 to 2018.
The approval was based on data from the KEYNOTE-224 study, a single-arm trial in patients with HCC who had disease progression on or after sorafenib or were intolerant to sorafenib; had measurable disease; and Child-Pugh class A liver impairment.
Losartan Potassium and Hydrochlorothiazide Tablets are approved to treat hypertension, alone or in combination with other antihypertensive drugs.
To ensure that the auto-injector can be easily removed from the carrier tube, healthcare providers should inspect the product prior to dispensing.
The new software enables patients to fine-tune the power level and modify programs that were pre-programmed by their clinician to control pain.
In the meeting documents, the panel presented a scenario which illustrated their concerns regarding potentially complex drug interactions that may occur in the population for which the drug is intended.
The FDA's marketing approval was supported by data from 690 women (aged 42 to 62 years) who were enrolled in the Study of Women's Health Across the Nation.
Epinephrine auto-injectors are indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis.
Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor, is being assessed in the ongoing Phase 3 POLO trial.
The petition was submitted by a number of non-profit organizations including the Center for Science in the Public Interest and the Breast Cancer Fund.
The FDA is not bound by the Committee's recommendation but takes it into consideration when making its decision.
The panel's decision was made based on data from from five Phase 3 studies and one Phase 4 trial which evaluated the safety and efficacy of prucalopride in patients with chronic constipation.
Alagille syndrome affects approximately 1 in 70,000 newborns.
Talzenna, a poly (ADP-ribose) polymerase (PARP) inhibitor, was evaluated in EMBRACA, an open-label trial that randomized patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer to receive talazoparib 1mg or physician's choice of chemotherapy.
The expanded approval was supposed by safety and efficacy data from the Phase 3 ACCESS IUS trial in women receiving Liletta.
The US Food and Drug Association has issued a draft guidance for helping prescription medications gain approval for nonprescription status.
Standard pen needles have an outer cover and removable inner needle cover, while safety pen needles have an outer cover and a fixed inner needle shield that is not removed before an injection.
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