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Results For "U.S.-Food-and-Drug-Administration"

594 News Found

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster
Clinical Trials | November 21, 2022

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster

Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data


Biocon Biologics features on ASIA IP ELITE List 2022
News | November 14, 2022

Biocon Biologics features on ASIA IP ELITE List 2022

This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list


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.


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.


Quizartinib granted priority review in the U.S.
Drug Approval | October 26, 2022

Quizartinib granted priority review in the U.S.

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone


Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis
Clinical Trials | October 13, 2022

Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis

68% of children on a higher dose of Dupixent achieved histological disease remission at week 16


Pfizer acquires Global Blood Therapeutics
News | October 09, 2022

Pfizer acquires Global Blood Therapeutics

Acquisition brings leading sickle cell disease portfolio and pipeline to Pfizer with potential to address critical needs in an underserved patient community


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


U.S. District Court rules in favor of Merck in Sitagliptin Phosphate patent lawsuit
News | September 23, 2022

U.S. District Court rules in favor of Merck in Sitagliptin Phosphate patent lawsuit

Sitagliptin is an active ingredient in JANUVIA, JANUMET and JANUMET XR


BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin
Drug Approval | September 22, 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.