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Results For "approval"

2623 News Found

Shionogi and MPP sign licence agreement for COVID-19 oral antiviral treatment
News | October 04, 2022

Shionogi and MPP sign licence agreement for COVID-19 oral antiviral treatment

Ensitrelvir is being evaluated for the treatment of COVID-19 to be administered as an oral tablet formulation taken once daily for five days.


Sumitovant Biopharma and Sumitomo Pharma to acquire outstanding shares of Myovant Sciences
News | October 03, 2022

Sumitovant Biopharma and Sumitomo Pharma to acquire outstanding shares of Myovant Sciences

The proposed acquisition consideration represents an equity value for Myovant of $2.4 billion and an enterprise value of $2.5 billion.


Japan homegrown COVID-19 mRNA vaccine needs superior safety and efficacy data for success, says GlobalData
News | October 01, 2022

Japan homegrown COVID-19 mRNA vaccine needs superior safety and efficacy data for success, says GlobalData

The booster vaccination trial is still ongoing and further data will provide more information around safety and efficacy.


USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility
Drug Approval | September 30, 2022

USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility

The company will address the observations within a stipulated timeline working with the regulators


Lupin launches Sildenafil for Oral Suspension in US
Drug Approval | September 30, 2022

Lupin launches Sildenafil for Oral Suspension in US

Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses


Aptar Pharma collaborates with Fluidda
News | September 25, 2022

Aptar Pharma collaborates with Fluidda

The companies will leverage their respective proprietary technology platforms


U.S. District Court rules in favor of Merck in Sitagliptin Phosphate patent lawsuit
News | September 23, 2022

U.S. District Court rules in favor of Merck in Sitagliptin Phosphate patent lawsuit

Sitagliptin is an active ingredient in JANUVIA, JANUMET and JANUMET XR


Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer
Drug Approval | September 23, 2022

Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer

One in two women with advanced ovarian cancer has an HRD-positive tumor


Cipla receives EIR for Indore plant, Aurbindo for Raleigh
News | September 23, 2022

Cipla receives EIR for Indore plant, Aurbindo for Raleigh

The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)