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Results For "FDA"

2061 News Found

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.


Balaxi conducts groundbreaking for its Rs 85 crore Hyderabad manufacturing facility
News | December 14, 2022

Balaxi conducts groundbreaking for its Rs 85 crore Hyderabad manufacturing facility

The investment will enable the company to enter European markets as well as enhance margins in current markets


US Federal Court dismisses cancer linkage associated with Zantac
News | December 13, 2022

US Federal Court dismisses cancer linkage associated with Zantac

The current ruling will assure the safety of the use of Ranitidine for Indian patients


Alembic receives EIR for oncology injectable formulation facility at Panelav
Drug Approval | December 12, 2022

Alembic receives EIR for oncology injectable formulation facility at Panelav

This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA


Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
News | December 05, 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule


Jemperli RUBY phase III trial met its primary endpoint
Clinical Trials | December 05, 2022

Jemperli RUBY phase III trial met its primary endpoint

Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


Orchid Pharma launches Rs. 500 Cr QIP programme
News | December 02, 2022

Orchid Pharma launches Rs. 500 Cr QIP programme

With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023


Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)
Drug Approval | November 30, 2022

Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)

Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.


Briefs: IOL Chemicals and Cipla
News | November 27, 2022

Briefs: IOL Chemicals and Cipla

Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".