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6841 News Found

Chantal van Gils joins NDA Advisory Board as Director of Epidemiology
People | November 27, 2022

Chantal van Gils joins NDA Advisory Board as Director of Epidemiology

She will provide strategic advice and scientific leadership to support clients in clinical development, registration strategy, submission, early post-approval strategy


Early detection of lung cancer vital to combat rising mortality rate, says GlobalData
News | November 27, 2022

Early detection of lung cancer vital to combat rising mortality rate, says GlobalData

The only definitive way to diagnose and stage lung cancers is through biopsies


Panchsheel Organics to set up fermentation/API unit
News | November 27, 2022

Panchsheel Organics to set up fermentation/API unit

Total investment envisaged in this project stands at up to Rs 70 crore


AstraZeneca receives import and market permission from CDSCO for Dapagliflozin
Drug Approval | November 26, 2022

AstraZeneca receives import and market permission from CDSCO for Dapagliflozin

The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals


Ministry of Ayush and DST sign MoU to identify areas of research
News | November 26, 2022

Ministry of Ayush and DST sign MoU to identify areas of research

The two have agreed to jointly undertake R&D activities on scientific validation of Ayush concepts, procedures and products


USFDA inspects Lupin's Mandideep Unit-1 facility
News | November 25, 2022

USFDA inspects Lupin's Mandideep Unit-1 facility

The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site


Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)


Neuland Laboratories appoints Abhijit Majumdar as CFO
People | November 24, 2022

Neuland Laboratories appoints Abhijit Majumdar as CFO

He brings over 30 years of experience across various organizations such as Asian Paints PPG, Berger Paints, Tata Steel, among others


USFDA issues warning letter to Glenmark's Goa manufacturing facility
News | November 24, 2022

USFDA issues warning letter to Glenmark's Goa manufacturing facility

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility