FDA Updates

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.

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.

The FDA approves guselkumab, the first IL-23 inhibitor for pediatric psoriasis and psoriatic arthritis, enhancing treatment options for children.

Biolinq Shine, a wearable biosensor, revolutionizes diabetes management with real-time glucose, activity, and sleep tracking.

Paltusotine, the first oral treatment for acromegaly, offers hope for improved patient care and management.

The approval is supported by clinical findings from the EMBER-3 trial.

The FDA linked cerebral folate deficiency to developmental delays with autistic features, although research remains ongoing.

However, experts say that a causal relationship between acetaminophen and autism has not been established.

The indication is for the treatment of adult and pediatric patients who weigh at least 30 kg.

Guselkumab becomes the first and only IL-23 inhibitor with a fully subcutaneous induction regimen for adults with ulcerative colitis.

The approval is supported by findings from the MK-3475A-D77 study.

With this approval, an effective, nonsteroidal treatment option is available for young patients.

West Coast states unite to enhance vaccine access and guidance for respiratory viruses, prioritizing public health and safety ahead of the 2025-2026 season.