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Results For "regulatory-filing"

90 News Found

OneSource Specialty Pharma appoints Jeffrey Wong as CBO
People | July 08, 2025

OneSource Specialty Pharma appoints Jeffrey Wong as CBO

He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations


Lupin and SteinCares ink agreement for Ranibizumab in Latin America
Supply Chain | May 26, 2025

Lupin and SteinCares ink agreement for Ranibizumab in Latin America

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A


Hikal posts Q4 FY25 consolidated PAT at Rs. 50 Cr
News | May 18, 2025

Hikal posts Q4 FY25 consolidated PAT at Rs. 50 Cr

In Q4 FY25, our pharmaceutical business reported revenue growth of 20% to Rs 351 crore and EBIT growth of 65% to Rs 55 croe, on QoQ basis


Zyuds Lifesciences receives USFDA approval for DMD treatment drug
Drug Approval | April 14, 2025

Zyuds Lifesciences receives USFDA approval for DMD treatment drug

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older


Sanofi India MD Rodolfo Hrosz to step down on April 30
People | April 11, 2025

Sanofi India MD Rodolfo Hrosz to step down on April 30

The board of directors accepted Hrosz’s resignation and expressed appreciation for his significant contributions during his tenure


Dr Reddy’s Laboratories gets Rs 2,395 crore show cause notice from IT authority
News | April 07, 2025

Dr Reddy’s Laboratories gets Rs 2,395 crore show cause notice from IT authority

Dr Reddy’s said scheme of amalgamation was carried with adherence to all the legal requirements including tax laws


Venus Remedies secures in-licensing rights from Infex Therapeutics to develop and commercialize MET-X in India
News | February 27, 2025

Venus Remedies secures in-licensing rights from Infex Therapeutics to develop and commercialize MET-X in India

MET-X, a novel metallo-beta-lactamase (MBL) inhibitor, has shown best-in-class performance in preclinical studies


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma
Drug Approval | November 25, 2024

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse


Alkem enters into licensing agreement with BioTherapeutics
News | October 11, 2024

Alkem enters into licensing agreement with BioTherapeutics

Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings