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Results For "Fast-Track-Designation"

36 News Found

Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’
Drug Approval | May 29, 2025

Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’

Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA


Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma
News | May 06, 2025

Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma

IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma


FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777
Drug Approval | October 08, 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy


GSK receives USFDA Fast Track designation for investigational vaccine against gonorrhoea
News | June 28, 2023

GSK receives USFDA Fast Track designation for investigational vaccine against gonorrhoea

Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing


Merck gets fast track designation from the USFDA for anticoagulant therapy
Drug Approval | August 24, 2022

Merck gets fast track designation from the USFDA for anticoagulant therapy

Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis


Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy
Drug Approval | February 20, 2022

Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy

Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear


USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine
Biotech | January 04, 2022

USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine

BPZE1 is the most advanced next-generation pertussis vaccine currently in clinical development


Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


Glenmark Pharma reports Q4 FY25 PAT at Rs. 346.6 Cr
News | May 24, 2025

Glenmark Pharma reports Q4 FY25 PAT at Rs. 346.6 Cr

Adjusted Profit After Tax (PAT) for the year ended March 31, 2025 was at Rs. 1,389.4 crore


Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer
Drug Approval | February 20, 2025

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved