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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.
“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.
The company is in various phases of clinical trials with PEGPH20 across multiple solid tumor types, including pancreatic cancer, non-small cell lung cancer (NSCLC), and gastric cancer, to test the drug's safety and efficacy. [3] Halozyme has one FDA approved product (Hylenex recombinant, hyaluronidase human injection [4] [5]).
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
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]
The FDA has granted Celgene's abraxane priority review as a first-line treatment for advanced pancreatic cancer, a move that shortens the normal review period by four months. In this video, health ...
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Irinotecan received accelerated approval from the US Food and Drug Administration (FDA) in 1996, [25] and full approval in 1998. [ 26 ] [ 27 ] [ 28 ] A liposome encapsulated version of irinotecan sold under the brand name Onivyde, was approved by the FDA in October 2015, to treat metastatic pancreatic cancer .
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