Diana Ernst, RPh

The decision to discontinue production was driven by business considerations rather than concerns about the product’s safety or effectiveness.

The FDA is expected to decide on treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone lymphoma, motion sickness, multiple sclerosis, and obstructive hypertrophic cardiomyopathy.

Brekiya is available with prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy.

The blood-based biomarker test measures Tau protein phosphorylated at threonine 181 in human plasma (pTau181).

ALTO-101 is an investigational phosphodiesterase-4 inhibitor delivered via a transdermal patch.

The SC formulation is supplied as a 360mg/1.8mL single-dose prefilled autoinjector.

The investigational agent is a humanized monoclonal antibody that targets multiple domains of the microtubule binding region of tau.

Bondlido is a drug-in-adhesive topical delivery system containing 200mg of lidocaine, an amide local anesthetic.

Subvenite oral suspension contains 10mg per mL of lamotrigine and is cherry-flavored.

The submission of additional analyses by Sanofi was deemed to be a major amendment to the application requiring a 3 month extension.

The announcement comes after a recently published review showed an association between prenatal acetaminophen exposure and an increased risk of autism.

According to Saol, the CRL included specific requirements that “would take several years and require significant financial resources.”

There are currently no FDA-approved treatments that address the underlying disease progression of MSA.

The decision was made based on data from the phase 2b/3 ORION trial.

Cemdisiran is a subcutaneously-administered, small interfering RNA therapeutic that reduces the production of complement factor 5 in the liver.

The IV formulation of efgartigimod alfa is currently approved under the brand name Vyvgart for the treatment of gMG in adult patients who are anti-acetylcholine receptor antibody positive.

Dusquetide is part of a new class of short, synthetic peptides known as innate defense regulators.

Moderna’s updated vaccines are expected to be available in the coming days.

The approval was supported by data from 3 double-blind, placebo-controlled trials that included a total of 1474 patients who met the 2016 ACR criteria for diagnosis of fibromyalgia.

The updated recommendations also address the link between high blood pressure and cognitive decline and dementia.

Genio is a bilateral hypoglossal nerve stimulation system that consists of an implantable stimulator and a sleep wearable.

The randomized, double-blind, CONVOKE trial evaluated the safety and efficacy of CT-155, a PDT that provides interactive psychosocial intervention techniques via a smartphone app.

The FDA is expected to decide on treatments for acromegaly, edema, HSCT-associated thrombotic microangiopathy, multiple sclerosis, and spinal muscular atrophy.

Modeyso is the first FDA-approved treatment for this rare brain tumor.

The sBLA for the pediatric indication is supported by data from the randomized, double-blind, placebo-controlled, phase 3 SPACE trial.

The phase 1b PRECISE-AD trial is currently investigating PMN310 in patients with mild cognitive impairment due to AD and in those with mild AD.

A phase 1 trial, LUMINA, is currently underway and is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMX0114 in approximately 48 patients with ALS.

A regulatory decision is expected in the fourth quarter of 2025.

Brekiya consists of dihydroergotamine mesylate, an ergotamine derivative, in a single-dose autoinjector for subcutaneous administration.

Atzumi is a drug-device combination consisting of dihydroergotamine, an ergotamine derivative.