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Results For "FDA"

1782 News Found

Sanofi reaffirms ambition to deliver >€10bn in annual vaccines sales by 2030
News | July 03, 2023

Sanofi reaffirms ambition to deliver >€10bn in annual vaccines sales by 2030

Intent to start at least 5 innovative Phase 3 vaccine programs by 2025


Rystiggo needs marketing strategy to fully compete in myasthenia gravis space, says GlobalData
News | June 30, 2023

Rystiggo needs marketing strategy to fully compete in myasthenia gravis space, says GlobalData

Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024


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


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 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.


Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ
News | June 17, 2023

Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ

Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma


Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
Drug Approval | June 16, 2023

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

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


Briefs: Natco Pharma and Panacea Biotec
Drug Approval | June 16, 2023

Briefs: Natco Pharma and Panacea Biotec

Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products


Airnov to showcase HDPE bottle range at upcoming CPHI China
News | June 15, 2023

Airnov to showcase HDPE bottle range at upcoming CPHI China

The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications