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Results For "regulatory"

1139 News Found

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer
Drug Approval | December 23, 2023

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients


Biocon Academy conducts 8th Graduation Day
News | December 19, 2023

Biocon Academy conducts 8th Graduation Day

Five batches across four programs of Biocon Academy participated in the graduation ceremony


Ami Organics inaugurates new API manufacturing facility
News | December 17, 2023

Ami Organics inaugurates new API manufacturing facility

This development is a strategic part of the company's commitment to bolstering its position in the advanced pharmaceutical intermediates segment


Venus Remedies expands global presence with marketing authorisation for enoxaparin from Azerbaijan
News | December 14, 2023

Venus Remedies expands global presence with marketing authorisation for enoxaparin from Azerbaijan

The company makes its maiden entry into Azerbaijan’s pharmaceutical market


Zydus inks licensing agreement with Daewoong Pharmaceutical for leuprolide injectable in the US
News | December 12, 2023

Zydus inks licensing agreement with Daewoong Pharmaceutical for leuprolide injectable in the US

The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome


Aptar Pharms opens new production facility at Taloja, Mumbai
News | December 10, 2023

Aptar Pharms opens new production facility at Taloja, Mumbai

New facility is part of Aptar Pharma’s global expansion program


Operations disrupted at NATCO Pharma's Manali, Chennai factory
News | December 08, 2023

Operations disrupted at NATCO Pharma's Manali, Chennai factory

NATCO temporarily shut down the operations due to cyclone with flooding/water logging of the factory premises


Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant
News | December 08, 2023

Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant

Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Drug Approval | December 08, 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions


Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug
News | December 07, 2023

Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug

Dr. Reddy's will make a US$ 7.5 million upfront payment to Coya