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Results For "approval"

2622 News Found

Dr. Reddy’s acquires trademark rights of breast cancer drug PRIMCYV from Pfizer
News | January 14, 2023

Dr. Reddy’s acquires trademark rights of breast cancer drug PRIMCYV from Pfizer

Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA


USFDA inspects Piramal Pharma Lexington facility
Drug Approval | January 12, 2023

USFDA inspects Piramal Pharma Lexington facility

The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.


Zydus launches Topiramate Extended-Release Capsules
Drug Approval | January 07, 2023

Zydus launches Topiramate Extended-Release Capsules

Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.


Helix and QIAGEN to jointly develop and commercialize companion diagnostics for hereditary diseases
Clinical Trials | January 06, 2023

Helix and QIAGEN to jointly develop and commercialize companion diagnostics for hereditary diseases

Partnership to leverage the Helix Laboratory Platform and QIAGEN's biopharma relationships, NGS capabilities, and global regulatory expertise


Provention Bio appoints Rita Jain to Board of Directors
People | January 06, 2023

Provention Bio appoints Rita Jain to Board of Directors

Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, AbbVie, Abbott Laboratories, and G.D. Searle and Co


Chindex Medical acquires 10 ViewRay MRIdian Systems for advanced cancer treatment
News | January 06, 2023

Chindex Medical acquires 10 ViewRay MRIdian Systems for advanced cancer treatment

Purchase agreement with ViewRay will make state-of-the art precision radiation therapy available in China


Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma
Drug Approval | January 05, 2023

Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma

Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.


USFDA grants appeal for Ardelyx's XPHOZAH
Drug Approval | December 31, 2022

USFDA grants appeal for Ardelyx's XPHOZAH

Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism


Hester to develop low pathogenic avian influenza inactivated vaccine for poultry
News | December 29, 2022

Hester to develop low pathogenic avian influenza inactivated vaccine for poultry

The company has plans to launch this Vaccine by the end of 2023 after completing the required field studies and obtaining regulatory approvals


World's first intranasal vaccine iNCOVACC will be rolled out in the fourth week of January
News | December 29, 2022

World's first intranasal vaccine iNCOVACC will be rolled out in the fourth week of January

The vectored intranasal delivery platform gives us the capability for rapid product development, scale-up, easy and painless immunization during public health emergencies and pandemics