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breakthrough therapy

FDA fast-tracks psilocybin treatment for major depressive disorder

The FDA has granted a Breakthrough Therapy designation to the Usona Institute for its trial use of psilocybin in the treatment of major depressive disorder (MDD), with the view of accelerating trials testing its efficacy.

Non-profit research organisation The Usona Institue is examining the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder.

Roche granted breakthrough therapy designation by FDA

Roche has announced that the FDA has granted its Actembra drug breakthrough therapy designation for giant cell arteritis. The breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to ensure that patients are able to have access to drugs as quickly as possible.

Celator receives FDA breakthrough therapy designation for leukaemia drug

A new treatment for acute myeloid leukaemia and other blood cancers from Celator Pharmaceuticals (NASDAQ: CPXX) has been granted breakthrough therapy designation from the US Food and Drug Administration (FDA).

MSD receives fourth Breakthrough Therapy Designation for Keytruda

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab) for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma.

This latest designation is the fourth that Keytruda has received from the FDA, who has also granted it breakthrough status for specific patients with advanced melanoma, advanced non-small cell lung cancer, and advanced colorectal cancer.

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