Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 4

Results For "prophylaxis"

69 News Found

USFDA accepts for priority review the sNDA for Merck’s Prevymis
Drug Approval | February 18, 2023

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients


Zydus launches Topiramate Extended-Release Capsules
Drug Approval | January 07, 2023

Zydus launches Topiramate Extended-Release Capsules

Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.


Takeda launches CINRYZE in India for hereditary angioedema patients
News | December 15, 2022

Takeda launches CINRYZE in India for hereditary angioedema patients

CINRYZE is plasma-derived C1-I NH approved for routine prevention (prophylaxis), short-term prevention or pre-procedure prevention, and acute attacks of HAE.


Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation
Clinical Trials | October 23, 2022

Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation

Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint


Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
Drug Approval | September 21, 2022

Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19

Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase III treatment trial


AstraZeneca likely to see substantial Evusheld uptake in Japan, says GlobalData
Drug Approval | September 13, 2022

AstraZeneca likely to see substantial Evusheld uptake in Japan, says GlobalData

Japan’s Ministry of Health, Labour and Welfare (MHLW) has recently approved AstraZeneca's long-acting antibody combination “Evusheld” for the prevention ) and treatment of COVID-19.


Roche gets USFDA approval of Xofluza to treat influenza in children
Drug Approval | August 13, 2022

Roche gets USFDA approval of Xofluza to treat influenza in children

Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age


Merck and Ridgeback announce new data for investigational molnupiravir
News | June 08, 2022

Merck and Ridgeback announce new data for investigational molnupiravir

Based on a post hoc analysis, fewer required respiratory interventions


Takeda launches Adynovate for Hemophilia patients in India
News | May 16, 2022

Takeda launches Adynovate for Hemophilia patients in India

Adynovate in combination with Mypkfit offers personalized treatment and enables HCPs and patients to monitor factor levels from home and help achieve optimum QOL outcomes