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Results For "filing"

549 News Found

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib
Drug Approval | October 09, 2023

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials


2654 compounds screened for different activities for GPCR profiling: Dr Jitendra Singh
Policy | March 16, 2023

2654 compounds screened for different activities for GPCR profiling: Dr Jitendra Singh

MoES have identified a potent Anti-cancer molecule named GS/IICT5/6


Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Drug Approval | February 25, 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma


Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe
Drug Approval | January 21, 2023

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions


Illumina unveils pathbreaking genomic profiling test for cancer in Europe
Medical Device | March 15, 2022

Illumina unveils pathbreaking genomic profiling test for cancer in Europe

The single in vitro diagnostic test helps inform therapy decisions according to clinical guidelines to enable precision medicine earlier in the disease journey


Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


Hansa Biopharma licenses IDEFIRIX to SERB Pharmaceuticals in €115 million deal
News | May 21, 2026

Hansa Biopharma licenses IDEFIRIX to SERB Pharmaceuticals in €115 million deal

SERB has a substantial European commercial presence and a successful track record in critical care and rare disease commercialization


National Genomics Infrastructure becomes first global certified core lab for Epigenica’s EpiFinder platform
R&D | May 21, 2026

National Genomics Infrastructure becomes first global certified core lab for Epigenica’s EpiFinder platform

NGI will deliver full end-to-end workflows using both EpiFinder cNUC and EpiFinder GenomePro


Bayer’s stroke drug wins fast-track review in US
Drug Approval | May 20, 2026

Bayer’s stroke drug wins fast-track review in US

The development comes as stroke remains one of the world’s biggest health threats


Precision oncology must be decentralized to reach every patient: Dr Vidya Veldore, Vice President, Clinical Operations, 4baseCare
interviews | May 18, 2026

Precision oncology must be decentralized to reach every patient: Dr Vidya Veldore, Vice President, Clinical Operations, 4baseCare

Access to genomic testing, not therapy cost, is the biggest challenge