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GSK receives USFDA Fast Track designation for investigational vaccine against gonorrhoea
News | June 28, 2023

GSK receives USFDA Fast Track designation for investigational vaccine against gonorrhoea

Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing


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


Ipca Laboratories receives 8 observations from USFDA
Drug Approval | June 24, 2023

Ipca Laboratories receives 8 observations from USFDA

The company will submit its comprehensive response on these observations to the USFDA


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


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