FDA Updates

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 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.

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.