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Results For "design"

1656 News Found

Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer
Drug Approval | January 08, 2026

Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer

Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis


SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer
Clinical Trials | December 29, 2025

SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer

The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38


FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer
Drug Approval | December 23, 2025

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care


Revvity unveils AI-powered Signals Xynthetica to accelerate molecular and materials design
Digitisation | December 17, 2025

Revvity unveils AI-powered Signals Xynthetica to accelerate molecular and materials design

The Signals Xynthetica solution brings AI-driven in-silico generation, predictive modeling, and experimental validation into a single, governed environment


Thermo Fisher opens Bioprocess Design Center in Hyderabad
Biopharma | December 09, 2025

Thermo Fisher opens Bioprocess Design Center in Hyderabad

Expands bioprocessing footprint across Asia


FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma
Drug Approval | November 12, 2025

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition


BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease
Drug Approval | October 05, 2025

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease


FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers
Drug Approval | September 16, 2025

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo


FDA grants Fast Track Designation for Teva’s Emrusolmin
Drug Approval | September 09, 2025

FDA grants Fast Track Designation for Teva’s Emrusolmin

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development


FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients
Drug Approval | August 18, 2025

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo