FDA Updates

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.

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

Additionally, the FDA granted a provisional interchangeability designation to both biosimilars.

Bumetanide nasal spray provides patients with edema an alternative to burdensome oral or intravenous diuretic options.

New FDA regulations are intended to enhance transparency in prescription drug advertising, empowering pharmacists to educate patients on medication risks and benefits.

GLSI-100 shows promise in preventing HER2-positive breast cancer recurrence after standard therapy.

Explore recent FDA-approved drugs from August 2025.

Selumetinib gains expanded FDA approval for younger pediatric patients with neurofibromatosis type 1 plexiform neurofibromas, enhancing treatment options and addressing significant disease-related challenges.

The FDA approves a groundbreaking gemcitabine system, offering new hope for patients with BCG-unresponsive bladder cancer.

FDA expands Vonvendi use for von Willebrand disease (VWD), enhancing treatment options for adults and children to manage bleeding effectively.

The FDA designates olomorasib as a breakthrough therapy, enhancing treatment options for advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations.

FDA approves a new extended-release suspension formulation of risperidone for schizophrenia, expanding treatment options for patients.

Zongertinib promises significant advancements in patient care.

This decision is believed to redefine how biological drugs will be developed, approved, and made affordable for patients.

The approval of 2 denosumab biosimilars, Bildyos and Bilprevda, enhances access to affordable bone health treatments for patients.

Rilzabrutinib gained FDA approval as the first BTK inhibitor for chronic immune thrombocytopenia, offering new hope for patients with persistent symptoms.

The subcutaneous injection for maintenance treatment enhances accessibility and reduces infusion time for patients.

The FDA has approved a ready-to-use long-acting injectable formulation that is administered every 3 months as a treatment for advanced prostate cancer.

The action is supported by 3 ongoing clinical trials, which are evaluating izalontamab brengitecan (iza-bren) in non–small cell lung cancer (NSCLC) and other diseases.

Allison Hill, PharmD, RPh, emphasized that pharmacists must stay updated on ACIP and state-level guidance following HHS’s changes to COVID-19 vaccine authorizations.