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3152 News Found

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir
News | June 27, 2023

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.


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


Moderna files for FDA authorization of its Covid-19 Vaccine
Drug Approval | June 27, 2023

Moderna files for FDA authorization of its Covid-19 Vaccine

Supply readiness follows months of manufacturing to ensure timely and ample supply


Venus Remedies receives approval to market meropenm in Spain
News | June 23, 2023

Venus Remedies receives approval to market meropenm in Spain

The company expects to capture a 10 per cent share in Spain’s $6.34 million meropenem market and consolidate its position in other European countries


Polyplastics announces commercial availability of DURACON POM PM Series for medical industry
News | June 23, 2023

Polyplastics announces commercial availability of DURACON POM PM Series for medical industry

The company will supply materials to all global regions including Asia such as China, India, Europe, and the U.S.


Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler
Drug Approval | June 22, 2023

Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler

This product will be manufactured at Lupin's Pithampur facility in India


DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine
News | June 21, 2023

DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine

The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield


Biostar Pharma receives FDA approval Utidelone Injectable Phase 2/3 clinical trial for cell lung cancer
Drug Approval | June 20, 2023

Biostar Pharma receives FDA approval Utidelone Injectable Phase 2/3 clinical trial for cell lung cancer

This trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable


Zydus receives final approval from the USFDA for Minocycline Hydrochloride ER Tablets
Drug Approval | June 20, 2023

Zydus receives final approval from the USFDA for Minocycline Hydrochloride ER Tablets

The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.


USFDA approves Roche’s Columvi for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma
Drug Approval | June 19, 2023

USFDA approves Roche’s Columvi for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma