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1369 News Found

Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis
Drug Approval | December 10, 2023

Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis

Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections


European Commission approves Pfizer’s Elrexfio for multiple myeloma
Drug Approval | December 09, 2023

European Commission approves Pfizer’s Elrexfio for multiple myeloma

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial


Zydus receives final approval from the USFDA for methylene blue injection
Drug Approval | December 07, 2023

Zydus receives final approval from the USFDA for methylene blue injection

Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product


Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets
Drug Approval | December 07, 2023

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa


Granules India received ANDA approval for Sildenafil for oral suspension
Drug Approval | December 06, 2023

Granules India received ANDA approval for Sildenafil for oral suspension

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million


Zydus receives final approval from the USFDA for Ivabradine Tablets
Drug Approval | December 06, 2023

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States


AstraZeneca Pharma India receives permission from CDSCO to import new drug
Drug Approval | December 04, 2023

AstraZeneca Pharma India receives permission from CDSCO to import new drug

The receipt of this permission paves way for the launch of BREZTRI AEROSPHERE in India


Strides launches Icosapent Ethyl Acid Soft Gel capsules in partnership with Amneal
News | December 02, 2023

Strides launches Icosapent Ethyl Acid Soft Gel capsules in partnership with Amneal

The product has been in-licensed from Strides and will be commercialized by Amneal


New global survey finds widespread misunderstandings about shingles despite its lifetime prevalence
News | December 01, 2023

New global survey finds widespread misunderstandings about shingles despite its lifetime prevalence

A new GSK survey shows a large number of adults do not understand how shingles may be triggered


Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial
Clinical Trials | November 29, 2023

Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial

Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease