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“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.
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 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]).
Bi-specific T-cell engager (BiTE) is a class of artificial bispecific monoclonal antibodies that are investigated for use as anti-cancer drugs. They direct a host's immune system, more specifically the T cells ' cytotoxic activity, against cancer cells.
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 .
Rucaparib, sold under the brand name Rubraca, is a PARP inhibitor used as an anti-cancer agent. [2] Rucaparib is a first-in-class pharmaceutical drug targeting the DNA repair enzyme poly-ADP ribose polymerase-1 (PARP-1). It is taken by mouth. [2] [4]
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 ...
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 ...