Agency IQ

AUGUST 16, 2024

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.

FDA 40

FDA Trials Regulations Therapies 40

Drug Discovery World

FEBRUARY 23, 2024

Voyager Therapeutics has announced new data from its two preclinical programmes targeting pathological tau for the treatment of Alzheimer’s disease. Based on these data, Voyager has advanced this programme into late research and expects to file an investigational new drug (IND) application in 2026.

Therapies 130

Therapies Pharmacokinetics RNA International 130

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Production 40