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Results For "USFDA-approval"

201 News Found

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


Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma
Drug Approval | January 05, 2023

Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma

Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.


Zydus receives final approval from USFDA for Lenalidomide Capsules
Drug Approval | September 15, 2022

Zydus receives final approval from USFDA for Lenalidomide Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India


My aim is to help the pharmaceutical industry develop a winning strategy: Dr Rupali Paranjape
interviews | May 23, 2022

My aim is to help the pharmaceutical industry develop a winning strategy: Dr Rupali Paranjape

Dr Rupali Paranjape, an experienced regulatory and compliance consultant and author of Blue Ocean of Compliance shares insights on her book in an interview with Thomas C Thottathil, Editor, www.indianpharmapost.com


USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis
Drug Approval | May 01, 2022

USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis

The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases


USFDA clears Kairos Pharma’s IND to treat prostrate cancer
Biotech | February 18, 2022

USFDA clears Kairos Pharma’s IND to treat prostrate cancer

Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope


Launches and margin sustainability hold key for Glenmark: ICICI Direct
News | February 15, 2022

Launches and margin sustainability hold key for Glenmark: ICICI Direct

Key takeaways of Q3FY22 quarter & conference call highlights


Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


Syngene reports better than expected revenues, margin pressure in Q1FY22: ICICI Direct
News | October 25, 2021

Syngene reports better than expected revenues, margin pressure in Q1FY22: ICICI Direct

Key takeaways of recent quarter & conference call highlights


Syngene revenue from operations up 17 per cent in Q2FY22
News | October 21, 2021

Syngene revenue from operations up 17 per cent in Q2FY22

The quarter also saw continued investment in new technologies and the successful implementation of several digitization and automation projects across operations