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"cdsco"

  • SEC recommends Biological E’s vaccine against Streptococcus pneumonia for infants

    Biological E Limited (BE) announced that the CDSCO approved the Phase 3 infants clinical trial data and recommended for manufacture of its 14-valent paediatric vaccine against Streptococcus pneumoniae infection in single-dose and multidose presentations.
  • Covaxin receives emergency use approval in children aged between 6 and 12

    Hyderabad: Bharat Biotech International announced that its Covaxin has received emergency use approval in children aged between 6 and 12 years. It had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity Covaxin in healthy children and adolescents in the 2-18 age group. The clinical trials conducted in the paediatric […]
  • CDSCO approves 2 new Covid vaccines, 1 anti-viral drug for restricted use

    New Delhi: Amid the ongoing resurgence of new Covid-19 cases in the country, an expert panel of the Central Drugs Standard Control Organisation has approved two new vaccines and one anti-viral drug for restricted use in emergency situation. The CDSCO has granted the Emergency Use Authorization (EUA) to COVOVAX, developed by the Serum Institute of […]
  • Open vial of Covaxin stable at 2-8°C for up to 28 days: Bharat Biotech

    Hyderabad: Explaining its 28 days open vial policy, Hyderabad-based Bharat Biotech on Monday stated that healthcare workers do not have to worry about opening Covaxin’s vial and its wastage. This means that an open Covaxin vial can be used up to 28 days post opening and would not go waste if there are no people […]
  • CDSCO approves extension of shelf life of Covaxin to 12 months

    Hyderabad: The shelf life of Hyderabad-based Bharat Biotech’s Covid-19 vaccine, Covaxin, has been extended to 12 months from the present nine months by the Central Drugs Standard Control Organisation (CDSCO). “The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life […]
  • India’s drug regulator approves study on mixing of Covaxin and Covishield doses

    An expert panel of the Central Drugs Standard Control Organisation (CDSCO) on July 29 had recommended granting permission for conducting the study.
  • One batch of Covaxin takes four months to manufacture and release

    For vaccines to result in actual vaccination of people, highly coordinated efforts are required from international supply chains, manufacturers, regulators and State and Central government agencies, says Bharat Biotech
  • Roche’s antibody Covid drug now available in India

    Roche is deeply committed to support the ongoing efforts to combat the Covid-19 pandemic, mitigate the deadly second wave and save lives
  • Covaxin emergency use authorisation approval a significant landmark: Dr Ella

    While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses
  • SII’s application for Covid vax emergency approval to be considered on Wednesday

    The development came after the UK became the first country in the world to approve a coronavirus vaccine developed by Oxford University and AstraZeneca, even as it battled the new highly contagious variant of the coronavirus.

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