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A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
Drugs granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough therapy can be awarded for multiple indications.
This drug is a kappa opioid receptor (KOR) antagonist—not to be confused with opioids, such as morphine and fentanyl. KOR antagonists, in fact, are the focus of research into treatment for ...
[4] [5] In 2019, nipolcalimab received orphan medicinal product designation by the European Medicines Agency for the treatment of HDFN. [6] In February 2024, nipocalimab was granted breakthrough therapy designation by the US Food and Drug Administration for the treatment of alloimmunized pregnant individuals at high risk of severe HDFN. [7] [8] [9]
It comes after the results from Lecanemab, the first drug to be hailed as a breakthrough for Alzheimer’s, were published last year. Researchers found that after 18 months, the drug slowed ...
The U.S. Food and Drug Administration is expected to approve a new drug called Leqembi in July. Here’s how Columbus helped make it happen.
In 2019, the US Food and Drug Administration (FDA) granted elafibranor breakthrough therapy designation, based on phase II data, for the treatment of primary biliary cholangitis in adults 18 and older with inadequate response to ursodeoxycholic acid (UDCA). [13] The designation was granted to Genfit. [13]
The Food and Drug Administration has granted "breakthrough therapy" status for Novartis' BYM338 drug, the company announced today, which could hasten regulatory review. The drug is designed to ...