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1783 News Found

USFDA approves Imjudo in combination with Imfinzi for liver cancer
Drug Approval | October 26, 2022

USFDA approves Imjudo in combination with Imfinzi for liver cancer

Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib


AstraZeneca updates on the MESSINA Phase III trial for Fasenra in eosinophilic esophagitis
Clinical Trials | 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.


Zydus receives final approval from USFDA for Micafungin for Injection
Drug Approval | October 26, 2022

Zydus receives final approval from USFDA for Micafungin for Injection

Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data


USFDA visit to Alembic Pharmaceuticals Panelav facility
Drug Approval | October 19, 2022

USFDA visit to Alembic Pharmaceuticals Panelav facility

None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable


Zydus receives tentative approval from USFDA for Roflumilast tablets
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Roflumilast tablets

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data


Zydus receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data


WHO, FAO, UNEP and WOAH launch One Health Joint Plan of Action
Policy | October 18, 2022

WHO, FAO, UNEP and WOAH launch One Health Joint Plan of Action

This first joint plan on One Health aims to create a framework to integrate systems and capacity so that we can collectively better prevent, predict, detect, and respond to health threats


ANDA approval from USFDA for Unichem's Extended Phenytoin Sodium Capsules
Drug Approval | October 15, 2022

ANDA approval from USFDA for Unichem's Extended Phenytoin Sodium Capsules

Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures


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