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8039 News Found

Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


Sai Ramana Ponugoti appointed as CEO, ICH of Piramal Pharma
People | January 07, 2025

Sai Ramana Ponugoti appointed as CEO, ICH of Piramal Pharma

Consequent to this appointment, Sarosh Shetty ceases to be Interim CEO of ICH.


Quality not just a measure, a way of life that drives innovation:  Renewable Energy Minister Joshi
News | January 07, 2025

Quality not just a measure, a way of life that drives innovation: Renewable Energy Minister Joshi

The cornerstone of the quality ecosystem is the implementation of the Quality Control Orders


Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation
Digitisation | January 07, 2025

Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation

NutrifyGenie AI, a leading AI-driven platform, was integral in designing scientifically differentiated formulations for a multinational client


Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary
News | January 07, 2025

Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary

These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route


Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara
News | January 07, 2025

Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara

The biosimilar Ustekinumab has been developed and manufactured by the company


Dr. Jitendra Singh announces CSIR's indigenously developed Paracetamol
News | January 06, 2025

Dr. Jitendra Singh announces CSIR's indigenously developed Paracetamol

40th DSIR Foundation Day celebration marks 16 more technology transfers from CSIR to MSMEs


ICMR detects two cases of HMPV in Karnataka through routine surveillance
News | January 06, 2025

ICMR detects two cases of HMPV in Karnataka through routine surveillance

ICMR will continue to track trends in HMPV circulation throughout the year


PM Modi lays foundation stone for new building for Central Ayurveda Research Institute in New Delhi
News | January 06, 2025

PM Modi lays foundation stone for new building for Central Ayurveda Research Institute in New Delhi

2.92 acre facility will combine tradition and innovation, offering new opportunities for holistic healing, specialized clinics, and skill development to be constructed at a cost of around Rs. 185 crore