Browsing Tag
FDA Orphan Drug Designation
6 posts
TuHURA Biosciences extends runway into 2028 as HURA investors wait for Merkel cell carcinoma data
TuHURA has bought time with a $50m facility. The harder test is whether IFx-2.0 can deliver before HURA investors lose patience.
Merck’s $6.7bn Terns Pharmaceuticals buy puts CML drug TERN-701 in play as Keytruda patent cliff nears
Merck agrees to acquire Terns Pharmaceuticals for $6.7B, adding TERN-701 CML drug to its oncology pipeline ahead of Keytruda's 2028 patent cliff. Read the full analysis.
BiVictriX Therapeutics receives FDA orphan drug designation for BVX001 in AML
BiVictriX Therapeutics plc (AIM: BVX), a prominent UK-based biotechnology firm, has reached a pivotal regulatory milestone as the…
Poseida Therapeutics gets FDA orphan drug designation for P-BCMA-ALLO1 in multiple myeloma
Poseida Therapeutics, Inc. (Nasdaq: PSTX), a trailblazer in the field of clinical-stage cell and gene therapy, has achieved…
Synspira’s PAAG15A receives orphan drug designation for cystic fibrosis treatment
Synspira Therapeutics’ investigational inhaled treatment, PAAG15A, has been granted orphan drug designation by the U.S. Food and Drug…
PharmaMar’s lurbinectedin granted orphan drug designation by FDA for small cell lung cancer treatment
Spanish pharmaceutical company PharmaMar has announced that its cancer drug, lurbinectedin, has received orphan drug designation from the…