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Results For "regulatory-approval"

316 News Found

Glenmark launches nasal spray to treat Covid-19
News | February 09, 2022

Glenmark launches nasal spray to treat Covid-19

Glenmark received manufacturing and marketing approval from DCGI for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process


Israel signs deal to purchase Novavax’ Covid-19 vaccine
Biotech | January 29, 2022

Israel signs deal to purchase Novavax’ Covid-19 vaccine

It would be the first protein-based alternative available in Israel


Philips introduces at-home, 12-lead ECG integrated solution for trials
Medical Device | January 26, 2022

Philips introduces at-home, 12-lead ECG integrated solution for trials

Philips expands remote cardiac monitoring portfolio with patch-based, clinical-grade ECG designed to improve patient recruitment, compliance and retention by reducing need for site visits during clinical trials


Eplontersen granted Orphan Drug Designation in the US
Biotech | January 24, 2022

Eplontersen granted Orphan Drug Designation in the US

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US


Alkem Labs to launch treatment for Diabetic Foot Ulcer
News | January 12, 2022

Alkem Labs to launch treatment for Diabetic Foot Ulcer

This advanced technology for Diabetic Foot Ulcer (DFU), management has a high scope of preventing amputations in diabetic patients. It has no definitive treatment in India. This technology will be available at affordable rates


ABL Bio collaborates with SANOFI for Parkinson’s antibody
Biotech | January 12, 2022

ABL Bio collaborates with SANOFI for Parkinson’s antibody

ABL and SANOFI to collaborate on the development of ABL301, a potential first-in-class bispecific antibody targeting alpha-synuclein and containing a proprietary brain shuttle, for alpha-synucleinopathies, including Parkinson's disease


Pfizer and Beam enter research collaboration for In Vivo base editing programme
Biotech | January 11, 2022

Pfizer and Beam enter research collaboration for In Vivo base editing programme

Four-year research collaboration combines Pfizer’s deep experience in global drug development, including programs utilizing messenger RNA (mRNA), lipid nanoparticles (LNP), and gene therapy, with Beam’s leadership in base editing and mRNA/LNP delivery technologies


Amyris and ImmunityBio JV for next gen Covid-19 RNA vaccine
Biotech | January 04, 2022

Amyris and ImmunityBio JV for next gen Covid-19 RNA vaccine

Upon completion of successful human trials and regulatory approval, the joint venture's goal is to start delivering the second-generation vaccine in 2022 as soon as is practically possible


Tan Thanh Holdings to pre-purchase 10 million doses of Covid-19 oral vaccines for ASEAN region
Biotech | December 30, 2021

Tan Thanh Holdings to pre-purchase 10 million doses of Covid-19 oral vaccines for ASEAN region

Oravax's oral VLP vaccine in development targets three SARS CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially more effective against current and future variants of the Covid-19 virus


U.S. FDA approves Leo Pharma’s Adbry
Drug Approval | December 29, 2021

U.S. FDA approves Leo Pharma’s Adbry

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022