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Syros Pharmaceuticals (SYRS) receives Orphan Drug designation from the FDA for its pipeline candidate AY-5609 being developed for treating metastatic pancreatic cancer. Stock up.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
“The FDA’s granting of orphan drug designation for IMM-1-104 underscores the urgent need for new therapies that meaningfully improve outcomes for pancreatic cancer patients and represents an important milestone in the development of our lead asset,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering.
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration. The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
The pancreatic cancer trials found that gemcitabine increased one-year survival rate significantly, and it was approved in the UK in 1995 [11] and approved by the FDA in 1996 for pancreatic cancers. [5] In 1998, gemcitabine received FDA approval for treating non-small cell lung cancer and in 2004, it was approved for metastatic breast cancer. [5]
On Wednesday, the FDA approved Merus N.V.’s (NASDAQ:MRUS) Bizengri (zenocutuzumab-zbco) as the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell ...
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