Breakthrough Therapies

Equipoise Lost? Trial Conduct Challenges in an Era of ...

Regulatory actions, such as breakthrough therapy designation or accelerated approval, may further support this perception, despite randomized ...

US drugmakers cheer 'speed lane' for breakthrough therapies

To be granted breakthrough designation, an experimental drug must show early indication of clinical improvement over existing therapies, even if ...

LSD D-Tartrate Receives Breakthrough Therapy Designation From ...

LSD d-tartrate (MM-120) showed rapid improvements in patients with generalized anxiety disorder by day 2 of the study.

Trends in breakthrough therapy designation | Nature Reviews Drug ...

Breakthrough therapy designation conveys similar features to fast track designation, priority review and accelerated approval, and is targeted in particular at ...

The Breakthrough Therapy Designation in China

Breakthrough Therapy Designation. The Breakthrough Therapy Designation intends to expedite the evaluation of medicines for critical diseases for which there are ...

Decisions on Non-oncology Breakthrough Therapy Designation ...

We reviewed Center for Drug Evaluation and Research (CDER) decisions to grant or deny breakthrough therapy designation requests for non-oncology drugs or ...

Breakthrough Therapies Research/Advisory Act. (P

For the purposes of this act, the term "breakthrough therapies" shall mean any drug. 13 that has been designated as a Breakthrough Therapy for ...

BeiGene Receives U.S. FDA Breakthrough Therapy Designation for ...

BeiGene receives US FDA breakthrough therapy designation for Zanubrutinib in mantle cell lymphoma.

Five Years of Breakthrough Therapies - YouTube

For the 21st Annual Cancer Leadership Awards Reception, Friends of Cancer Research honored the fifth year of the breakthrough therapy ...

Syndax Announces U.S. FDA Breakthrough Therapy Designation ...

Revumenib is the first and only investigational treatment for R/R KMT2Ar acute leukemia to receive Breakthrough Therapy Designation.

Boehringer receives U.S. FDA Breakthrough Therapy designation ...

The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated ...

U.S.C. Title 21 - FOOD AND DRUGS - GovInfo

Expedited approval of drugs for serious or life-threatening diseases or conditions. (a) Designation of a drug as a breakthrough therapy. (1) In general. The ...

FDA Grants Breakthrough Therapy Designation to Experimental FTD ...

The Food and Drug Administration has granted a Breakthrough Therapy Designation to latozinemab, an experimental treatment for FTD-GRN.

Press Release Details - Agios Pharmaceuticals, Inc.

Agios Receives FDA Breakthrough Therapy Designation for TIBSOVO® (ivosidenib) for the Treatment of Adult Patients with Relapsed or Refractory Myelodysplastic ...

FDA Grants Breakthrough Therapy Designation for IPF

Announcement that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the novel investigational therapy, ...

Imfinzi granted Priority Review and Breakthrough Therapy ...

This Priority Review reinforces the potential of Imfinzi to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival ...

Soleno Therapeutics Receives Breakthrough Therapy Designation ...

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to diazoxide choline for the treatment of adults and children ages 4 ...

Breakthrough Therapy Efforts Result in Unprecedented Success

The FDA can designate a new drug as breakthrough therapy if it is intended to treat a serious or life-threatening disease.

Impacts of the breakthrough therapy designation on drug R&D

By revealing a surge of new indications entering the development process without a corresponding reduction in productivity, our findings support the prediction ...

New Breakthrough Therapy for Metastatic Melanoma Receives FDA ...

New Breakthrough Therapy for Metastatic Melanoma Receives FDA Approval ... A first-of-its-kind cellular immunotherapy pioneered at Moffitt Cancer ...