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3152 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


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


Zydus receives final USFDA approval for Erythromycin Tablets
Drug Approval | September 03, 2023

Zydus receives final USFDA approval for Erythromycin Tablets

Erythromycin tablets is used to prevent and treat infections in many different parts of the body


USFDA delegation visits Amneal Pharmaceutical facility in Matoda
News | September 02, 2023

USFDA delegation visits Amneal Pharmaceutical facility in Matoda

Amneal’s site in Matoda is one of the company’s 12 pharmaceutical manufacturing facilities


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


Strides receives USFDA approval for Mycophenolate Mofetil for oral suspension
Drug Approval | August 31, 2023

Strides receives USFDA approval for Mycophenolate Mofetil for oral suspension

The approval bolsters the company's Mycophenolate Mofetil portfolio


Lupin receives USFDA approval for Pirfenidone Capsules
Drug Approval | August 31, 2023

Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US