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The approval is based on data from a multicenter trial in which patients were randomized 2:1 to receive either 30 mcg of the sufentanil sublingual tablet as needed, or placebo, with treatment limited up to 48 hours following the procedure.

The committee jointly voted 21-2 against recommending approval, noting that the benefit-risk profile was not adequate to support approval.

This approval marks the first and only oral film approved by the FDA to treat seizures associated with Lennox-Gastaut syndrome.

Hyperkalemia increased the risk of 30-day readmissions.

Clobazam oral film (Sympazan) is the first and only FDA-approved oral film formulation to treat seizures associated with Lennox-Gastaut syndrome.

Top news of the week from Specialty Pharmacy Times.

Top news of the day from across the health care landscape.

Top news of the day from across the health care landscape.

This list encompasses over 50 companies in the digital health space attempting to improve medication adherence, ranging from bioingestible sensors to smart pill bottles.

The guidelines also highlight the importance of discussions between health care providers and patients.

Tanezumab (Eli Lilly and Pfizer) reduced osteoarthritis pain by 50% or greater in more than half of patients in a study.

Officials with the FDA have approved Sandoz’s adalimumab-adaz (Hyrimoz), a biosimilar of Humira.

Top news of the day from across the health care landscape.

Top news of the day from across the health care landscape.

All-oral direct-acting antivirals had a significant effect on the clinical and economic outcomes of patients with hepatitis C virus in the 4 years following the approval of these treatments.

Phase 2b study results show durable responses rates and symptom improvement in patients with psoriatic arthritis.

The test is the first of its kind to secure FDA approval.

A total of 85% of AMBER study participants (308/362) achieved virologic suppression (viral load

The recalls and returns will be managed by the respective distributors separately, according to a press release from the company.

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

Adalimumab-adaz (Hyrimoz), a biosimilar of Humira, is the third FDA-approved Sandoz biosimilar in the United States.

Health systems and manufacturers need to work together to obtain inclusion for health system specialty pharmacies so that patients can fill their prescriptions within a coordinated care ecosystem.

This approval marks the first anti-PD-1 regimen for the first-line treatment of squamous non-small cell lung cancer regardless of tumor expression status.

The expanded indication marks the first time an anti-PD-1 regimen has been approved in the first-line setting as both combination and monotherapy for squamous NSCLC, regardless of tumor PD-L1 expression status.

Officials with the FDA have approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

Hepatitis B virus infectivity can remain stable for up to 9 months and demonstrate high resilience to antiseptics.

Preliminary data show that treatment with anti-PD-1 inhibitors may be feasible in patients with HIV and cancer.

Top news of the day from across the health care landscape.

Top news of the day from across the health care landscape.