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Results For "FDA"

2075 News Found

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer
Biotech | April 08, 2022

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer

The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC


MakGroup Healthcare becomes sole distributor of PixCell Medical's HemoScreen in the UAE
News | April 07, 2022

MakGroup Healthcare becomes sole distributor of PixCell Medical's HemoScreen in the UAE

Exclusive distribution agreement brings Point-Of-Care (POC) haematology diagnostics to new regions in the Middle East


Good business performance gives Boehringer Ingelheim tailwind for investment in R&D
Biotech | April 05, 2022

Good business performance gives Boehringer Ingelheim tailwind for investment in R&D

R&D investment up 11.7% to 4.1 billion EUR in 2021 (20.0% of net sales)


Suven Pharmaceuticals acquires Casper Pharma for Rs 155 crore
News | April 05, 2022

Suven Pharmaceuticals acquires Casper Pharma for Rs 155 crore

Casper Pharma is a Hyderabad based SEZ company engaged in the formulations business. Post-purchase of shares, the target entity would become a wholly-owned subsidiary of SPL


Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Biotech | April 01, 2022

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product


Oragnon enters global licencing agreement with Dare Biosciences
News | April 01, 2022

Oragnon enters global licencing agreement with Dare Biosciences

An estimated 21 million American women experience BV


BioVaxys expands cancer vaccine platform
Biotech | March 31, 2022

BioVaxys expands cancer vaccine platform

BVX-0922 to target colorectal cancer under investigator-sponsored IND


CerroZone reduces airborne Covid-19 Delta variant by 99.998% in 1.2 seconds
Biotech | March 31, 2022

CerroZone reduces airborne Covid-19 Delta variant by 99.998% in 1.2 seconds

Air purification system achieves Intertek zero ozone certification


Sanofi and IGM Biosciences team up to commercialise IgM antibody agonists
Biotech | March 30, 2022

Sanofi and IGM Biosciences team up to commercialise IgM antibody agonists

Companies to leverage proprietary IgM antibody technology platform to discover agonists against three oncology targets and three immunology/inflammation targets


ASC Therapeutics gets green light to advance gene therapy for Hemophilia A
Biotech | March 30, 2022

ASC Therapeutics gets green light to advance gene therapy for Hemophilia A

A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies