Articles related to FDA

FDA priority review vouchers granted to three psychedelic developers and a recent executive order may accelerate regulatory timelines for psilocybin and related compounds, with clinical availability potentially within 12 months pending positive Phase 3 data.

The FDA approved a supplemental NDA adding randomized withdrawal trial data to the lumateperone label, supporting its role in long-term maintenance and relapse prevention in adults with schizophrenia.

A nationwide recall of more than 3 million OTC eye drops due to sterility concerns highlights the importance of routine patient counseling around non‑prescription ocular products.

Reproxalap is an investigational drug candidate for the treatment of dry eye disease.

“Today’s approval of the first generic fluticasone propionate inhalation aerosol represents an important step in expanding access to affordable asthma treatment.” – Iilun Murphy, MD, Director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research

The new chemical entity is an atypical antipsychotic and the active metabolite of iloperidone (Fanapt). Its ability to cross the blood-brain barrier likely contributes to iloperidone’s clinical effects.