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Results For "tolerability"

182 News Found

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
Drug Approval | November 11, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster

The European Commission will review the CHMP recommendation and is expected to make a final decision soon.


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


AstraZeneca updates on the MESSINA Phase III trial for Fasenra in eosinophilic esophagitis
Diagnostic Center | October 26, 2022

AstraZeneca updates on the MESSINA Phase III trial for Fasenra in eosinophilic esophagitis

High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints.


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


Boehringer Ingelheim InPedILD Phase III trial showed encouraging results for both primary endpoints
Diagnostic Center | September 06, 2022

Boehringer Ingelheim InPedILD Phase III trial showed encouraging results for both primary endpoints

New data from Boehringer Ingelheim support the potential use of nintedanib in children and adolescents with fibrosing interstitial lung disease


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


Wockhardt announces successful initiation of Global Phase 3 Clinical Study of its novel antibiotic WCK 5222
Diagnostic Center | August 16, 2022

Wockhardt announces successful initiation of Global Phase 3 Clinical Study of its novel antibiotic WCK 5222

WCK 5222 is a Super-drug which is entirely a new class of antibiotic known as "?-lactam ENHANCER".


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


U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | July 15, 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


Ascentage Pharma gets IND clearance by the US FDA for novel EED Inhibitor APG-5918
Drug Approval | July 02, 2022

Ascentage Pharma gets IND clearance by the US FDA for novel EED Inhibitor APG-5918

This multicenter, open-label Phase I study is designed to assess the safety and tolerability