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Results For "NDA"

4806 News Found

ABDM supports the integration of digital health infrastructure
Digitisation | July 24, 2023

ABDM supports the integration of digital health infrastructure

Health-tech startups have the potential to revolutionize the healthcare sector by supporting innovations


Apollo performs 23000+ multi-organ transplantation
Healthcare | July 24, 2023

Apollo performs 23000+ multi-organ transplantation

Apollo Transplant program is the first program in India to cross the landmark of 18500 kidney transplants, 4300 liver transplants and 500 pediatric liver transplants


India brings traditional medicine at the forefront of India’s G20 presidency discourse: Amitabh Kant
News | July 24, 2023

India brings traditional medicine at the forefront of India’s G20 presidency discourse: Amitabh Kant

Traditional medicine effectively highlighted in all health and engagement working groups meeting and Ministry of Ayush acknowledges these efforts


USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
Drug Approval | July 24, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories


Merck receives positive European Union CHMP opinion for Gefapixant
News | July 22, 2023

Merck receives positive European Union CHMP opinion for Gefapixant

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union


Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin
News | July 22, 2023

Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin

Good momentum in commercial CDMO business


Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
Drug Approval | July 22, 2023

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU


Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826
News | July 21, 2023

Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826

The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023


Merck’s Phase 3 Keynote- A18 trial met PFS in patients with advanced cervical cancer
Clinical Trials | July 21, 2023

Merck’s Phase 3 Keynote- A18 trial met PFS in patients with advanced cervical cancer

KEYTRUDA plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients