Articles related to DEVICE/DRUG APPROVALS

Neffy®, an FDA-approved intranasal epinephrine spray, demonstrates bioequivalence to injectable epinephrine for anaphylaxis treatment in patients weighing ≥30kg, potentially reducing barriers to rapid intervention.

Zunveyl, a prodrug of galantamine, has been formulated to minimize gastrointestinal absorption, potentially addressing common tolerability issues associated with acetylcholinesterase inhibitors in Alzheimer’s treatment.

Afamitresgene autoleucel offers a novel approach to treating metastatic synovial sarcoma, with an overall response rate of 43.2% in clinical trials, providing a much-needed alternative to traditional chemotherapy.

Roflumilast cream 0.15% demonstrates rapid and significant improvement in itch within 24 hours of the first application, addressing a primary concern for atopic dermatitis patients.

Kisunla’s approval introduces a novel treatment option for early Alzheimer’s disease, potentially altering the landscape of AD management with its ability to significantly reduce amyloid plaque levels and slow cognitive decline.

The FDA has approved a combination therapy of pembrolizumab, carboplatin, and paclitaxel for advanced endometrial cancer, significantly enhancing progression-free survival rates for patients with both mismatch repair deficient and proficient statuses.