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Results For "filing"

511 News Found

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


GSK Pharma shareholders back Ronojit Biswas’ Board, CFO appointment via postal ballot
News | April 09, 2026

GSK Pharma shareholders back Ronojit Biswas’ Board, CFO appointment via postal ballot

Both ordinary resolutions sail through with over 99.6% votes in favour, strengthening leadership continuity at the drugmaker


Solara Active Pharma dispatches final rights share call notice; Rs 112.5 per share due by May 7
News | April 08, 2026

Solara Active Pharma dispatches final rights share call notice; Rs 112.5 per share due by May 7

API maker begins circulation of second and final call money notice for partly paid-up rights shares, completing the last leg of its 2024 fundraising cycle


Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity
Drug Approval | April 08, 2026

Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity

Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size


Aurobindo Pharma wins USFDA approval for generic Xigduo XR
Drug Approval | April 08, 2026

Aurobindo Pharma wins USFDA approval for generic Xigduo XR

Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually


Merck moves to seal $53-a-share takeover of Terns Pharmaceuticals
News | April 08, 2026

Merck moves to seal $53-a-share takeover of Terns Pharmaceuticals

The acquisition aims to bolster Merck’s hematology portfolio with Terns’ lead oncology candidate, TERN-701