Specialty Pharmacy

The FDA recommends the dosage of givinostat (Duvyzat; Italfarmaco, ITF Therapeutics) should be based on the individual’s body weight and administered twice daily with food.

The BLA includes all indications for Xolair, including asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergy, and chronic spontaneous urticaria.

The efficacy data are consistent with other phase 3 studies, reinforcing lebrikizumab's potential as a first-line treatment across a range of skin tones.

Oteseconazole (Vivjoa; Mycovia Pharmaceutical Inc) is the first and only medication for this indication in postmenopausal women and those who do not have reproductive potential.

The FDA-approved topical and oral agent is currently indicated for adult patients with patterned alopecia.

The accelerated approval of resmetirom, a once-daily, oral thyroid hormone receptor-β agonist, is the first treatment available for patients with this disease.

The IVIG therapies were previously approved for 4-week room temperature storage conditions of 25º Celsius during the first 24 months of shelf life.

The biosimilarity was evident between SB17 (Samsung Bioepis), ustekinumab (Stelara; Janssen Immunology), and those switching from ustekinumab to SB17.

The FDA is convening a committee to discuss phase 3 data after the planned action date, which delays drug availability to patients.

The study is a companion study to the ROCKstar study, which investigated the drug in individuals with cGVHD who received 2 to 5 prior lines of therapy.

“I see clinical pharmacy specialists (CPS) to be more like the frontline folks that would pretty much work very closely with the providers,” according to a CPS at City of Hope.

Denosumab-bbdz (Wyost; Sandoz) and denosumab-bbdz (Jubbonti; Sandoz) are approved as interchangeable for all indications of denosumab (Xgeva and Prolia; Amgen).

In the study, investigators found superior kidney outcomes with injectable semaglutide (Ozempic) for individuals with type 2 diabetes and chronic kidney disease.

Juvéderm Voluma XC (AbbVie) is the first and only hyaluronic acid dermal filler to receive FDA approval for this indication with results lasting up to 13 months.

AAO-HNSF guideline development group included 17 panel members, including experts from otolaryngology and allergy, those who have knowledge in clinical practice guideline development, and patient representatives.

Jon Martin, US commercial lead of biosimilars at Organon, discusses how making their biosimilar Hadlima the preferred product on the Veteran Affairs formulary will help lower treatment costs.

This grant funding is a part of the company’s 3-year Setting the P.A.C.E. initiative.

Pharmacy's position at the intersection of the care team gives it a unique ability to connect providers, payers, and pharmaceutical manufacturers, and support patients to maximize their health outcomes.

In addition to highlighting the difficulties patients face when managing plaque psoriasis and atopic dermatitis, 2 experts describe how pharmacists play a crucial role in treatment.

Teclistamab was previously approved in October 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma who received at least 4 prior therapies.

If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved, calling for a reschedule of MDMA from Schedule I. A PDUFA was set for this summer.

Fouad Atouf, senior vice president of global biologics at US Pharmacopeia, discusses how established quality standards, drawing from the realm of small molecule drugs and evolving to meet the complexities of biologics, play a pivotal role in fostering trust.

Bepirovirsen is a triple action investigational antisense oligonucleotide and is being evaluated in the B-Well phase 3 clinical trial program for the treatment of chronic hepatitis B.

AI can pair people to foods that are best suited for their unique needs, according to a food-as-medicine entrepreneur.

Fouad Atouf, senior vice president of global biologics at US Pharmacopeia, discusses the importance of robust quality standards in addressing concerns regarding biosimilar safety and efficacy.

The model was designed to help improve health outcomes, improve access to care, and lower costs for gene therapy.

The company seeks the approval for both the intravenous and subcutaneous administration routes.

Switching from adalimumab originator to SB5 did not cause clinically significant differences in treatment efficacy and safety for patients with noninfectious uveitis.

The company will discontinue the development and commercialization of aducanumab-avwa (Aduhelm) for intravenous use and will terminate the ENVISION clinical study.

Afami-cel had engineered t-cell receptor T-cells target MAGE-A4+ tumors, which are highly expressed in synovial sarcoma with HLA-A*02.