Risultati per: FDA approva un nuovo trattamento per l’emicrania

Circulation, Volume 148, Issue 4, Page 309-311, July 25, 2023.

Prevede l’utilizzo di un anticorpo monoclonale come cura preventiva

La malattia spesso ereditaria riguarda 100 mila italiani

Riduce il rallentamento cognitivo del 28% in 18 mesi

Alzheimer disease drugs that receive traditional approval from the US Food and Drug Administration (FDA) will be covered under Medicare for patients who qualify for them, the Centers for Medicare & Medicaid Services (CMS) announced.

A new, “easy-to-read” standardized document proposed by the US Food and Drug Administration (FDA) would help patients use their prescription drugs or biological products more safely and effectively, the agency said in a statement.

This Viewpoint discusses a recent federal court decision that invaliated the Food and Drug Administration’s (FDA) approval of mifepristone, a drug used to end pregnancies and manage miscarriage when used with misoprostol, and how that decision challenges the legitimacy and independence of the FDA.

The US Food and Drug Administration (FDA) approved an extended-release buprenorphine injection, sold as Brixadi, as a treatment for moderate to severe opioid use disorder. The drug is available as a weekly or monthly formulation in varying doses, providing “a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence,” the FDA wrote in an announcement.

A combination of oral nirmatrelvir and ritonavir tablets, marketed as Paxlovid, recently received full US Food and Drug Administration (FDA) approval for managing mild to moderate COVID-19 infections in adults who are at high risk of developing severe disease. Paxlovid was previously granted Emergency Use Authorization in December 2021.

An insulin pump and dosing software from Beta Bionics were recently approved by the US Food and Drug Administration (FDA) for managing type 1 diabetes in people aged 6 years or older. Together, the pump, software, and a previously approved continuous glucose monitor form an “automated insulin dosing system” called the iLet Bionic Pancreas, the FDA announced in a statement.

The US Food and Drug Administration (FDA) approved prescription nalmefene hydrochloride nasal spray, an opioid receptor antagonist. Nalmefene, sold as Opvee, can be used to treat adults and children aged 12 years or older who are experiencing a known or suspected opioid overdose, according to the FDA’s statement.

This Viewpoint discusses how sex and gender subpopulations may be differentially affected by tobacco products and suggests that the FDA formulate regulations in clinically meaningful ways.

La scoperta può aiutare a riconoscere le persone più a rischio

Brexpiprazole, marketed as Rexulti, was granted supplemental approval on May 11 by the US Food and Drug Administration (FDA) for treating agitation linked with Alzheimer disease, the most common cause of dementia. Approval for the drug is based on results from 2 phase 3 randomized clinical trials that showed “statistically significant and clinically meaningful improvements” in caregiver-reported agitation symptoms for patients receiving 2 or 3 mg of brexpiprazole compared with those receiving a placebo, according to the FDA’s statement.

The nonhormonal drug fezolinetant is the first of its kind to be approved by the US Food and Drug Administration (FDA) to treat moderate to severe hot flashes—periods of sweating, flushing, and chills—associated with menopause, the agency announced in a statement. Fezolinetant, marketed as Veozah, targets the neurokinin 3 receptor to restore the brain’s regulation of body temperature.