FDA Updates

The FDA approves a simplified single-injection treatment for ulcerative colitis, enhancing patient experience with monthly dosing convenience.

The FDA updates sotatercept's label, enhancing treatment options for pulmonary arterial hypertension and reducing severe clinical events.

Elinzanetant, the first FDA-approved nonhormonal treatment for menopause-related hot flashes, offers women a new, effective relief option.

Revumenib was approved for adults and pediatric patients 1 year and older with relapsed or refractory acute myeloid leukemia.

FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma, enhancing treatment options and survival rates for patients with limited therapies.

The FDA approves obinutuzumab (Gazyva; Genentech) for lupus nephritis, offering a new treatment option with improved renal outcomes for patients.

The expanded indications now include adolescents with hidradenitis suppurativa aged 12 and older and pediatrics with uveitis aged 2 and older.

The FDA approves a groundbreaking 1-minute HIV self-test, enhancing accessibility and empowering individuals to manage their health discreetly.

The approved indication now includes adults with moderately to severely active ulcerative colitis and Crohn disease who have not been treated with tumor necrosis factor blocking agents.

The move emphasizes the need for vigilant monitoring.

FDA approves Uzedy, an extended-release injectable formulation of risperidone, enhancing treatment options for adults with bipolar I disorder.

The FDA approves Eydenzelt, a biosimilar for retinal diseases, enhancing treatment options for diabetic macular edema and age-related macular degeneration.

Explore recent FDA-approved drugs from September 2025.

Ron Lanton advises pharmacies to maintain compliance, explore contingency options, and stay engaged with policymakers during the government shutdown.

Pharmaceutical companies navigate FDA regulations and explore AI solutions to enhance compliance in drug advertising and enforcement.

Cemiplimab's approval is supported by findings from the C-POST clinical trial.

This is the first pediatric FDA approval for golimumab, according to the manufacturer.

The FDA approves nerandomilast, the first new treatment for idiopathic pulmonary fibrosis in over a decade, offering renewed hope for patients.

Explore the evolving role of pharmacists in navigating FDA regulations and the impact of drug ads on patient care.

The approval is supported by findings from the INTEGUMENT-PED trial and the INTEGUMENT-OLE long-term extension study.

This is the second generic version of mifepristone to be approved by the FDA.

The approval was based on positive efficacy and safety indications from the IMforte clinical trial of patients with extensive-stage small cell lung cancer (SCLC).

FDA enhances oversight of drug ads using AI to ensure compliance, addressing risks and benefits in direct-to-consumer advertising.

BATURA demonstrated that albuterol/budesonide significantly reduced severe exacerbation risk reduction in patients with mild asthma.

Remibrutinib gains FDA approval as the first oral treatment for chronic hives, offering hope for patients unresponsive to standard therapies.

Umoja Biopharma's UB-VV111 gains FDA fast track designation, revolutionizing CAR T-cell therapy for relapsed lymphoma and leukemia patients.

The new formulation of intravenous immunoglobulin (IVIG) provides patients another option to help reduce the incidence of severe bacterial infections.