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CDSCO approves Boehringer Ingelheim’s drug as first treatment for heart failure...

With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance® is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction

Govt’s MedTech regulation currently applies to select equipment: AHPI DG

As per Dr Girdhar Gyani, Director General, Association of Healthcare Providers (AHPI), the regulation needs to be extended to other equipment to avoid substandard equipment in the Indian market........................

Roche receives approval for laboratory based Elecsys SARS-CoV-2 antigen test

The Elecsys SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of active SARS-CoV-2 infection....................

Roche gets DCGI nod for its investigational antibody cocktail in India

Casirivimab and Imdevimab is indicated for the treatment of mild to moderate Covid-19 in high-risk patients........................

Mankind Pharma seeks CDSCO’s nod to conduct phase-1 clinical trials of...

A patented first in class novel anti-diabetic molecule, MKP10241 is a potent and orally administered small molecule, GPR119 agonist.........................

Advancements in digital technology critical to clinical trials: Experts

Across the pharmacovigilance, biostatistics, medical writing and clinical data management sessions, panelists spoke of the digital-enabled regulatory flexibility during the pandemic........................

Wait over as DCGI approves Bharat Biotech & Serum Institute COVID-19...

After adequate examination, Central Drugs Standard Control Organisation decided to accept the recommendations of the Expert Committee, and accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in an emergency situation

Zydus seeks approval to commence Phase III clinical trials of its...

New Delhi: Zydus Cadila has announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe, well tolerated and immunogenic in...

India taking baby steps to harmonize international regulatory standards for medical...

As per Dr V G Somani, Drugs Controller General of India, the medical device industry needs to look at quality, affordability, and access, and service delivery while developing products from a pricing and regulatory perspective..........................

MTaI welcomes CDSCO’s latest move to boost ease of doing business...

Medical Technology Association of India has welcomed two latest notices from the Central Drugs Standard Control Organization (CDSCO) that address operational and regulatory challenges faced by the medical device industry...........