Select Page
BioCardia: CardiAMP System to Treat Heart Failure

BioCardia: CardiAMP System to Treat Heart Failure

Feb 4, 2022 | FDA, News, Regulatory

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...
FDA Approval: Prophylactic Treatment for Type 3 VWD

FDA Approval: Prophylactic Treatment for Type 3 VWD

Jan 31, 2022 | FDA, News, Regulatory

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

ALX Oncology: Evorpacept Receives ODD to Treat GC

Jan 28, 2022 | FDA, News, Regulatory

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...
Pidnarulex: FDA Fast Track to Treat Solid Tumors

Pidnarulex: FDA Fast Track to Treat Solid Tumors

Jan 25, 2022 | FDA, News, Regulatory

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...