Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
BioCardia: CardiAMP System to Treat Heart Failure
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the BioCardia’s CardiAMP® Cell Therapy System designed for the treatment of heart failure. Heart Failure (HF) is a complex, progressive clinical syndrome that affects the...
Moderna’s COVID-19 Vaccine SPIKEVAX Snatches FDA Approval
The US Food and Drug Administration (FDA) has recently approved Moderna’s mRNA COVID-19 vaccine, SPIKEVAX, becoming the second COVID-19 vaccine to be fully approved in the US. Now marketed under the name SPIKEVAX, the vaccine’s name references the spike-like...
FDA Designation: THE-630 to Treat Gastrointestinal Tumors
Theseus Pharmaceuticals announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for THE-630 to treat patients with advanced gastrointestinal stromal tumors (GIST). GIST is the most common sarcoma of the gastrointestinal tract, and...
Azafaros: ODD for AZ-3102 to Treat GM2 Gangliosidosis
Azafaros has announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for AZ-3102 to treat GM2 gangliosidosis, including Tay-Sachs disease and Sandhoff disease. GM2 gangliosidosis, a group of rare genetic disorders that...
FDA Approval: Prophylactic Treatment for Type 3 VWD
The U.S. Food and Drug Administration (FDA) has approved Takeda Pharmaceutical’s VONVENDI to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease (VWD). VWD is the most common inherited bleeding disorder that is caused by a...
ALX Oncology: Evorpacept Receives ODD to Treat GC
The U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) for ALX Oncology’s evorpacept, a next-generation CD47 blocker, to treat patients with gastric cancer and gastroesophageal junction cancer. Gastric cancer and gastroesophageal...
Immunocore: FDA Clearance of Uveal Melanoma Drug KIMMTRAK
The U.S. Food and Drug Administration (FDA) has granted approval of Immunocore’s KIMMTRAK (tebentafusp-tebn) to treat adults who are HLA-A*02:01-positive for unresectable or metastatic uveal melanoma (mUM). Uveal melanoma is a rare and aggressive cancer of the eye, in...
Imara IND Clearance: Tovinontrine (IMR-687) to Treat HFpEF
The U.S. Food and Drug Administration (FDA) has cleared Imara’s Investigational New Drug (IND) application for tovinontrine (IMR-687) to treat heart failure with preserved ejection faction (HFpEF). HFpEF (diastolic heart failure) is a form of heart failure that occurs...
Pidnarulex: FDA Fast Track to Treat Solid Tumors
Senhwa Biosciences’ Pidnarulex (CX-5461) has been granted a Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of solid tumors with BRCA1/2, PALB2, and other gene mutations. In patients with solid tumors, specifically breast...
FDA Approval: IND for APS03118 to Treat Multiple Cancers
In regulatory news today, the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application from Applied Pharmaceutical Science for its breakthrough drug, APS03118, to target multiple advanced cancer types. APS03118 has...
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