Articles related to FDA

Erzofri offers a new once-monthly injectable option for treating schizophrenia and schizoaffective disorder, potentially improving medication adherence for some patients.

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.

The FDA advisory committee’s decision highlights the complexities of perioperative treatment in NSCLC and the need for more precise efficacy data to guide clinical decision-making.

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.