breakthrough therapy

Showing 4 posts of 4 posts found.


FDA fast-tracks psilocybin treatment for major depressive disorder

November 25, 2019
Sales and Marketing Controlled Substance Act, FDA, breakthrough therapy, major depressive disorder, psilocybin

The FDA has granted a Breakthrough Therapy designation to the Usona Institute for its trial use of psilocybin in the …

Roche granted breakthrough therapy designation by FDA

October 5, 2016
Research and Development Actemra, FDA, Giant Cell arteritis, Roche, breakthrough therapy

Roche has announced that the FDA has granted its Actembra drug breakthrough therapy designation for giant cell arteritis. The breakthrough …


Celator receives FDA breakthrough therapy designation for leukaemia drug

May 20, 2016
Medical Communications, Research and Development FDA, Vyxeos, acute myeloid leukaemia, breakthrough therapy, celator

A new treatment for acute myeloid leukaemia and other blood cancers from Celator Pharmaceuticals (NASDAQ: CPXX) has been granted breakthrough …


MSD receives fourth Breakthrough Therapy Designation for Keytruda

April 19, 2016
Manufacturing and Production, Research and Development Breakthrough Therapy Designation, FDA, Hodgkin lymphoma, MSD, Merck, breakthrough designation, breakthrough therapy, keytruda

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab) …

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