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J&J makes submission to WHO for Emergency Use Listing of Janssen COVID-19 vaccine
The data package delivered includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial
CCI commences consultation process for pharma study
The study is being done with a view to developing a better understanding of the competition landscape in the sector
Dr Reddy’s initiates process for EUA of Sputnik V
As part of the review process, Dr Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3…
Bharat Biotech seeks approval for COVID-19 vaccine in over 40 countries
Pricing of COVAXIN for international markets will be based upon supply timelines, purchase commitments and procurement volumes,…
Aurobindo Pharma receives USFDA nod for Droxidopa Capsules
The product will be launched immediately
Lupin gets US FDA approval for Droxidopa Capsules
The product will be manufactured at Lupin’s facility in Nagpur, India
Zydus Cadila gets final nod from USFDA for Droxidopa Capsules
It is indicated for use in people with conditions of the nervous system that can cause low blood pressure
Unichem Laboratories gets USFDA approval for Apremilast Tablets
Apremilast tablets are indicated for the treatment of plaque psoriasis
Eli Lilly enters into $960 million deal with Rigel Pharma to develop autoimmune therapy
Under the deal, Lilly will foot the costs of global commercialisation for the therapy, R552, and Rigel will have the right to…
Shilpa Medicare gets Import Alert from USFDA
Three products have been exempted from the Import Alert - Azacitidine for Injection, Cyclophosphamide Capsules and Erlotinib…