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Results For "approval"

2476 News Found

Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | January 19, 2023

Stelis Biopharma’s flagship facility receives EIR from USFDA

The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes


USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions
Drug Approval | January 17, 2023

USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions

The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22


USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility
Drug Approval | January 16, 2023

USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility

The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations


Granules India’s Gagillapur facility completes USFDA inspection
Drug Approval | January 16, 2023

Granules India’s Gagillapur facility completes USFDA inspection

The company will respond to these observations within the stipulated time period.


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