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Results For "FDA-approval"

438 News Found

Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr
News | August 09, 2023

Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr

US FDA approval is in line with de-risking strategy for additional API site to service our global customer base


Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Drug Approval | August 01, 2023

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy


Syngene Q1 FY 2024 revenue up 26% to Rs. 832 crores, PAT up 26% to Rs.93 Cr
News | July 26, 2023

Syngene Q1 FY 2024 revenue up 26% to Rs. 832 crores, PAT up 26% to Rs.93 Cr

Acquisition of biologics manufacturing facility in Bangalore to complete by the end of the third quarter in FY 24


USFDA approves Pfizer’s Litfulo for adults and adolescents with severe alopecia areata
Drug Approval | June 27, 2023

USFDA approves Pfizer’s Litfulo for adults and adolescents with severe alopecia areata

LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12


USFDA approves Injectafer for the treatment of iron deficiency in adult patients with heart failure
Drug Approval | June 06, 2023

USFDA approves Injectafer for the treatment of iron deficiency in adult patients with heart failure

Injectafer is now the first and only intravenous (IV) iron replacement therapy indicated for adult patients with heart failure who have iron deficiency


Farxiga’s expanded approval highlights potential to differentiate in HF space, says GlobalData
News | May 17, 2023

Farxiga’s expanded approval highlights potential to differentiate in HF space, says GlobalData

Farxiga is expected to have such a strong influence on the market due to the impressive results


USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause
Drug Approval | May 13, 2023

USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause


Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment
Drug Approval | May 03, 2023

Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment

It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment


USFDA Advisory Committee votes  n Lynparza plus Abiraterone and Prednisone  for prostate cancer
Drug Approval | May 03, 2023

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients


Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, says GlobalData
News | April 08, 2023

Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, says GlobalData

FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop