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Results For "approval"

2477 News Found

Insmed announces positive results from Phase III arise study of ARIKAYCE
News | September 06, 2023

Insmed announces positive results from Phase III arise study of ARIKAYCE

Patients Treated with ARIKAYCE plus macrolide-based background regimen had meaningfully larger improvements in QOL-B respiratory score


Cipla Medpro South Africa to acquire Actor Pharma
News | September 05, 2023

Cipla Medpro South Africa to acquire Actor Pharma

This is a strategic acquisition for Cipla South Africa to unlock the future growth opportunities in the South African market


Caplin Steriles receives EIR from US FDA
Drug Approval | September 05, 2023

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated


Amgen settles with FTC over US$28 billion deal
Policy | September 04, 2023

Amgen settles with FTC over US$28 billion deal

Amgen will be prohibited from leveraging its drug portfolio to disadvantage rivals and will be required to seek prior approval before acquiring related products


BioNTech to lead $2 billion mRNA-based oncology therapy market despite challenges, says GlobalData
News | September 03, 2023

BioNTech to lead $2 billion mRNA-based oncology therapy market despite challenges, says GlobalData

BioNTech's diverse pipeline includes multiple drugs in Phase I, II, and III clinical trials


USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes
Drug Approval | September 01, 2023

USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes

Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia


Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules
Drug Approval | August 31, 2023

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR


European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ
Drug Approval | August 30, 2023

European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ

KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population


Novo Nordisk, Eli Lilly record growth in Q2 driven by obesity, diabetes drug sales
News | August 30, 2023

Novo Nordisk, Eli Lilly record growth in Q2 driven by obesity, diabetes drug sales

Novo Nordisk’s GLP-1 Ozempic has reported a YoY increase in revenue from $2.1 billion to $3.2 billion