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Results For "Fast-Track-Designation"

61 News Found

iRegene Therapeutics secures series B+ financing
Biotech | September 12, 2025

iRegene Therapeutics secures series B+ financing

NouvNeu001 is the world’s first allogeneic iPSC-derived cell therapy for Parkinson’s disease to receive this designation


FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia
Drug Approval | September 02, 2025

FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia

ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life


Boehringer’s lung cancer medicine gets FDA approval
Drug Approval | August 12, 2025

Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC


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


Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Drug Approval | October 16, 2024

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally


Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain
Drug Approval | September 06, 2024

Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain

This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II


Merck announces Phase 3 trial initiation for Bomedemstat
Clinical Trials | August 27, 2024

Merck announces Phase 3 trial initiation for Bomedemstat

The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)


Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows achieved groundbreaking results in liver disease due to MASH
Clinical Trials | February 28, 2024

Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows achieved groundbreaking results in liver disease due to MASH

Survodutide has potential to become best-in-class treatment for metabolic dysfunction-associated steatohepatitis


Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab
News | January 29, 2024

Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America