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Results For "regulatory-approvals"

167 News Found

Shionogi and MPP sign licence agreement for COVID-19 oral antiviral treatment
News | October 04, 2022

Shionogi and MPP sign licence agreement for COVID-19 oral antiviral treatment

Ensitrelvir is being evaluated for the treatment of COVID-19 to be administered as an oral tablet formulation taken once daily for five days.


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU
News | September 05, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine


Aurobindo Pharma to invest Rs 300 crore on mammalian cell culture manufacturing facility
News | September 02, 2022

Aurobindo Pharma to invest Rs 300 crore on mammalian cell culture manufacturing facility

The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers


Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate
Clinical Trials | July 28, 2022

Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate

This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.


SKYCovione will strengthen South Korea position in global COVID-19 vaccine industry, says GlobalData
News | July 27, 2022

SKYCovione will strengthen South Korea position in global COVID-19 vaccine industry, says GlobalData

This will not only strengthen the country’s overall position in the global vaccine industry but also reduce its reliance on foreign vaccines


Syngene reports revenue from operations up 8% in Q1 FY 23
News | July 21, 2022

Syngene reports revenue from operations up 8% in Q1 FY 23

Company raises the annual revenue guidance from mid-teens to high teens


Syngene signs 10-year biologics manufacturing agreement with Zoetis
News | July 15, 2022

Syngene signs 10-year biologics manufacturing agreement with Zoetis

Syngene's collaboration with Zoetis started in 2011


Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine
News | June 30, 2022

Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine

105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses


Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron
News | June 27, 2022

Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron

Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine