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Results For "supplemental-Biologics-License-Application"

43 News Found

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.

Latest Stories

Eye-Q upgrades advanced affordable eye care facility in Lucknow

NIPER, Raebareli signs technology transfer pact with Lofty Laboratories

Artemis Medicare Q4 FY26 revenue rises 16.4% to Rs. 27,923 lakh, net profit jumps 32.1%

White Papers

Chasing Consistency: Centralizing operations data is the key to optimizing chemicals plants

Implementing a digital transformation in chemical operations to maximize profitability

The complexity of compliance

The Sprint to the Summit: Unlocking Lab Efficiency through Digital Transformation

The guiding role of fluidized and spouted bed technologies in particle building processes

Interviews
Agentic AI poised to reshape pharma operations beyond pilot-stage adoption: Duraisamy Rajan Palani, Founder & CEO, Archimedis Digital
Agentic AI poised to reshape pharma operations beyond pilot-stage adoption: Duraisamy Rajan Palani, Founder & CEO, Archimedis Digital
Duraisamy Rajan Palani Founder and CEO, Archimedis Digital
Patient-centric innovation driving fight against neglected diseases: Sanjay Sarin, Continental Lead Asia and South Asia Director, DNDi
Patient-centric innovation driving fight against neglected diseases: Sanjay Sarin, Continental Lead Asia and South Asia Director, DNDi
Sanjay Sarin, Continental Lead Asia and South Asia Director, DNDi
Our hybrid model combines global manufacturing with local clinical scale: Kavinder Beniwal, Chief Operational Officer, Motorica India
Our hybrid model combines global manufacturing with local clinical scale: Kavinder Beniwal, Chief Operational Officer, Motorica India
Kavinder Beniwal Chief Operational Officer, Motorica India

Packaging