List of drugs granted breakthrough therapy designation information

Drugs granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough...

Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section...

The FDA granted Patisiran (Onpattro) orphan drug status and breakthrough therapy designation due to its novel mechanism involving RNA therapy to block...

and Drug Administration describes the designation of breakthrough therapy as "a process designed to expedite the development and review of drugs that...

effects Drugs by psychological effects Psychoactive drugs The Food and Drug Administration describes the designation of breakthrough therapy as "a process...

drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority...

function. The U.S. Food and Drug Administration (FDA) granted this a breakthrough therapy designation to accelerate the trial and approval process. In 2016...

govitecan-hziy was granted accelerated approval along with priority review, breakthrough therapy, and fast track designations. The U.S. Food and Drug Administration...

Act. A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. RMAT goes beyond breakthrough therapy features by allowing...

breakthrough therapy designation for treatment of haemophila A in those who have not developed resistance to other treatments. The U.S. Food and Drug...

which furthered the drug's clinical trials. In July 2014, the FDA granted breakthrough therapy status to blinatumomab for the treatment of acute lymphoblastic...

and Drug Administration (FDA) granted the application for idecabtagene vicleucel breakthrough therapy and orphan drug designations. The FDA granted approval...

Food and Drug Administration (FDA) granted onasemnogene abeparvovec-xioi various designations including fast track, breakthrough therapy, priority review...

priority review, breakthrough therapy, and orphan drug designations. In the United States, Janssen received breakthrough therapy designation for talquetamab...

journals. In 2017, the FDA granted breakthrough therapy designation for its use with psychotherapy for PTSD. However, this designation has been questioned and...

Axicabtagene ciloleucel was awarded U.S. Food and Drug Administration (FDA) breakthrough therapy designation in October 2017, for diffuse large B-cell lymphoma...

baseline. The FDA granted the application for etranacogene dezaparvovec priority review, orphan drug, and breakthrough therapy designations. In November 2022...

Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals classified as high-cost, high complexity and/or high touch. Specialty...

Against Cystic Fibrosis". Forbes. 18 July 2017. "FDA approves new breakthrough therapy for cystic fibrosis". FDA. 21 October 2019. Parsons, Lucy (24 October...

Anti-infective Cures AG. US FDA granted Fast Track Designation for pritelivir in 2017. US FDA granted Breakthrough Therapy Designation for pritelivir in 2020....

firadenovec priority review, breakthrough therapy, fast track, and orphan drug designations. The FDA granted approval of Adstiladrin to Ferring Pharmaceuticals...

for and won a breakthrough therapy designation for the drug. This regulatory pathway was new at the time and not well understood. One of its advantages...

rights to the drug from Genmab. Daratumumab was granted breakthrough therapy drug status in 2013, for multiple myeloma. It was granted orphan drug status for...

maraleucel priority review, orphan drug, regenerative medicine advanced therapy (RMAT), and breakthrough therapy designations. Lisocabtagene maraleucel is the...

company PsychoGenics. The U.S. Food and Drug Administration has granted ulotaront the breakthrough therapy designation. In addition to schizophrenia, ulotaront...

track designation for the treatment of excessive daytime sleepiness and cataplexy in people with narcolepsy, and breakthrough therapy designation for the...

August 2022. The FDA granted Zynteglo orphan drug and breakthrough therapy designations for the treatment of TDT. Skysona: In July 2021 the company received...

Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a...

University of Pennsylvania, and is licensed to Novartis. In April 2017, tisagenlecleucel received breakthrough therapy designation by the U.S. Food and Drug Administration...