Pharmabiz

Zydus receives US FDA Orphan Drug Designation for desidustat to treat sickle cell disease

Zydus receives US FDA Orphan Drug Designation for desidustat to treat sickle cell disease: Our Bureau, Mumbai Friday, February 6, 2026, 16:30 Hrs [IST] Zydus, a leading, discovery ...

Zydus’ Desidustat gets Orphan Drug Designation from U.S. FDA for Sickle Cell disease

Zydus on Friday said U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) to Desidustat for the treatment of Sickle Cell Disease (SCD).
CURE

FDA Grants Orphan Drug Designation to Zenocutuzumab for Cholangiocarcinoma

FDA orphan designation for zenocutuzumab‑zbco targets NRG1 fusion–positive advanced cholangiocarcinoma, a small molecular subset within an aggressive malignancy with <15% five-year survival. Orphan ...
Pharmabiz

US FDA grants orphan drug designation to Imviva Biotech’s CTD402 for the treatment of T-cell leukaemia and lymphoma

US FDA grants orphan drug designation to Imviva Biotech’s CTD402 for the treatment of T-cell leukaemia and lymphoma: Boston Friday, January 30, 2026, 17:00 Hrs [IST] Imviva Biot ...

Atossa Therapeutics Receives FDA Orphan Drug Designation for (Z)-Endoxifen for the Treatment of Duchenne Muscular Dystrophy

Endoxifen program into rare pediatric neuromuscular disease along with previously received Rare Pediatric Disease Designation SEATTLE, /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa ...
CURE

FDA Grants Orphan Drug Status to IFx-2.0 for Advanced Melanoma Care

The FDA has granted orphan drug designation to IFx-2.0 for patients with stage 2B to stage 4 cutaneous melanoma. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the ...

SCYNEXIS Receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designations for SCY-247

The QIDP designation will ensure at least 10 years of market exclusivity for SCY-247 following approvalRecent articles highlight the growing ...