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Results For "FDA"

1707 News Found

Novatek Pharma initiates Phase II study of oral COVID-19 drug
Drug Approval | August 14, 2021

Novatek Pharma initiates Phase II study of oral COVID-19 drug

This therapy may provide the first potential oral treatment for COVID-19, recognizing the global emergency of new SARS-CoV-2 variants


Aurobindo Pharma buys Cronus Pharma Specialities for Rs 420 crores
News | August 13, 2021

Aurobindo Pharma buys Cronus Pharma Specialities for Rs 420 crores

The acquisition will provide it with a foothold in the US $ 48 billion global animal health market


Unichem Labs receive ANDA approval for Metformin Hydrochloride
News | August 13, 2021

Unichem Labs receive ANDA approval for Metformin Hydrochloride

It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


Syngene sets up microbial facility as it expands biopharma-manufacturing capacity
Biotech | August 13, 2021

Syngene sets up microbial facility as it expands biopharma-manufacturing capacity

It strengthens Syngene’s portfolio as a fully integrated custom biomanufacturer with added mammalian and microbial capabilities for clinical and commercial supplies


Human studies begin on AI discovered COVID-19 treatment with up to 97% effectiveness
Drug Approval | August 12, 2021

Human studies begin on AI discovered COVID-19 treatment with up to 97% effectiveness

A treatment to prevent extreme symptoms and cut hospitalisation


SAB Biotherapeutics nonclinical data indicates SAB-185 neutralizes Delta and Lambda SARS-CoV-2 Variants
Drug Approval | August 12, 2021

SAB Biotherapeutics nonclinical data indicates SAB-185 neutralizes Delta and Lambda SARS-CoV-2 Variants

SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial


Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee
Drug Approval | August 12, 2021

Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee

The company is eligible for 12 months exclusivity from launch


Tesis Labs and Personal Genome Diagnostics tie-up to advance cancer treatment
Digitisation | August 11, 2021

Tesis Labs and Personal Genome Diagnostics tie-up to advance cancer treatment

The aim is to create new genomics solutions that could combat cancer and advance market access


Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China
Biotech | August 11, 2021

Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China

The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial


GSK files application for MMR vaccine in the US
News | August 11, 2021

GSK files application for MMR vaccine in the US

If approved it will bring a second source of MMR vaccine to the US market