Regulatory Pathway– tag –
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Solu Therapeutics’ STX-0712 with CyTAC™ Technology Granted FDA Fast Track for Relapsed or Refractory CMML
Pharma News (citing Solu Therapeutics) USA Overview Solu Therapeutics announced that STX-0712, utilizing its CyTAC™ technology, received FDA Fast Track designation for relapsed or refractory chronic myelomonocytic leukemia (CMML). STX-07... -
NovaBridge Biosciences’ Givastomig Secures FDA Fast Track for HER2-Negative Metastatic Gastric Cancer
Cancer Network (citing NovaBridge Biosciences) USA Overview NovaBridge Biosciences' CLDN18.2 x 4-1BB bispecific antibody, givastomig, has received FDA Fast Track designation for HER2-negative metastatic gastric cancer. This designation i... -
Biogen’s Salanersen Granted FDA Breakthrough Therapy Designation for SMA Patients with Suboptimal Gene Therapy Response
Cure SMA USA Overview Biogen's investigational spinal muscular atrophy (SMA) therapy, salanersen, has received Breakthrough Therapy Designation from the FDA. This designation is based on promising Phase 1b data in pediatric SMA patients ... -
Halia Therapeutics’ Ofirnoflast (HT-6184) Receives FDA Fast Track Designation for Lower-Risk MDS
BioUtah USA Overview Halia Therapeutics' Ofirnoflast (HT-6184), an oral NEK7 allosteric modulator for lower-risk myelodysplastic syndromes (LR-MDS), has been granted FDA Fast Track designation. This decision follows promising Phase 2 dat... -
FDA Grants Breakthrough Therapy Designation to Merck’s Investigational KRAS G12C Inhibitor Calderasib (MK-1084) in Combination with KEYTRUDA for Metastatic NSCLC
BioSpace USA Overview Merck announced that its investigational oral KRAS G12C inhibitor, calderasib (MK-1084), in combination with KEYTRUDA® (pembrolizumab), received FDA Breakthrough Therapy Designation for newly diagnosed metastatic KR... -
Biogen’s Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy (SMA)
PMLiVE USA Overview Biogen's investigational antisense oligonucleotide (ASO), salanersen, has received FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy (SMA). This designation is based on early clinical data showing impro... -
FDA Grants Fast Track Designation to Investigational Gene Therapy for Rare Inherited Eye Disease
FDA Press Release USA Overview The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to an investigational gene therapy for a serious rare inherited eye disease. This designation aims to facilitate development an... -
Arvinas Secures IND Clearance for Oral LRRK2 Degrader ARV-102, Expanding Neurodegenerative Pipeline and Partnering with Michael J. Fox Foundation
Arvinas Press Release / MarketBeat / GLOBE NEWSWIRE USA Overview Arvinas announced FDA approval of its Investigational New Drug (IND) application for ARV-102, an oral PROTAC protein degrader designed for specific neurodegenerative diseas... -
Regulatory & Policy Shifts Reshape Global Biologics Manufacturing Strategy: Focus on EU Reform, UK Decentralization, and US Tariffs
IMAPAC UK Overview Regulatory and policy shifts, including EU Pharma Reform, UK decentralized manufacturing initiatives, and U.S. tariffs, are fundamentally reshaping global biologics manufacturing strategies. Notably, the UK has establi... -
US Department of Veterans Affairs Launches MDMA-Assisted Mental Health Therapy Trial
VA News (US Department of Veterans Affairs) USA Overview The U.S. Department of Veterans Affairs (VA) has initiated a clinical trial for MDMA-assisted mental health therapy, following the FDA's Breakthrough Therapy designation for MDMA, ...
