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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


Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss
News | June 28, 2023

Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss

As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands


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


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


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


Lupin launches Thiamine Hydrochloride Injection USP in the US
Drug Approval | June 19, 2023

Lupin launches Thiamine Hydrochloride Injection USP in the US

Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.