Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with Hepatocellular Carcinoma (HCC)• Announced Agreement with Roche to Support Advancement ...

Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with ...

The FDA granted an orphan drug designation to PEP-010 for the treatment of patients with metastatic pancreatic cancer.

ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA ...

Initiated IND-enabling toxicology program IND submission planned for 4Q25; Clinical data expected in 1H26 CRANBURY, N.J., March 25, 2025 /PRNewswire/ -- Palatin ...

today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for RCT2100, a novel, investigational mRNA therapy being developed to treat cystic fibrosis (CF).

Although itolizumab did not improve response rates at Day 29 for patients with acute GVHD, the therapy showed significant ...

AccurEdit Therapeutics today announced that its innovative in vivo gene editing product, ART001, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA).

Two Democratic commissioners of the Federal Trade Commission sued the Trump administration after being fired before their ...

Kedaara Capital and TA Associates are in talks to acquire a significant minority stake in Sagent Pharma, valued at $500-600 ...

"With strongly anchored pipelines, key global partnerships and deliberate plans to navigate regulatory pathways, we believe ...

CRANBURY, N.J. - Palatin Technologies, Inc. (NYSE American: PTN) has received orphan drug designation from the U.S. Food & Drug Administration (FDA) for PL7737, an investigational oral treatment ...