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  • Novavax gets DCGI approval for 12 year olds

    Novavax, Inc a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the worlds largest vaccine manufacturer by volume, announced that the Drugs Controller General of India has granted emergency use authorization (EUA) for Novavax protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India.

  • New Drug Molnupiravir Get DCGI Approval, Can It Be the Solution for the Fight Against COVID-19

    As countries prepare themselves to fight a possible ‘next wave’. The new variant – Omicron has been making headline and a surge in Covid 19 cases are evident. According to a study based on population-level evidence, the recently identified Omicron variant of SARS-CoV-2 is associated with a substantial ability to evade immunity from prior Covid-19 infection. Omicron is also considered to be three times more transmissible than the Delta variant.

    admin Wed, 01/05/2022 - 15:52
  • Hyrdroxyurea approved by DCGI for Sickle cell anemia

    Sickle cell anemia (SCA) is a common genetic disorder affecting red blood cells in the Indian population. The disease is passed on to children with the faulty beta globin gene from their parents, although the parents themselves do not get the disease. About 0.4% of the population suffers from the disease, while 10% are carriers of the disease, giving rise to new SCA patients.

  • Sun Pharma receives DCGI approval for Molnupiravir in India

    Sun Pharma announced that one of its wholly owned subsidiaries has received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of MSD (a trade name of Merck & Co., Inc, Kenilworth, NJ, USA) and Ridgebacks molnupiravir under the brand name Molxvir in India. Earlier this year, Sun Pharma had signed a nonexclusive voluntary licensing agreement with MSD to manufacture and supply a generic version of molnupiravir in over 100 low and middle-income countries (LMICs) including India.

  • AstraZeneca Pharma India Limited receives Import and Market Permission in Form CT-20 from the Drugs Controller General of India for Selumetinib 10 mg & 25 mg Capsule

    AstraZeneca Pharma India Limited has received Import and Market Permission in Form CT-20 from the Drugs Controller General of India for Selumetinib 10 mg & 25 mg capsule.

    Selumetinib can also cause cardiomyopathy, ocular toxicity including retinal vein occlusion, retinal pigment epithelial detachment and impaired vision, and increased creatinine phosphokinase. Selumetinib should be withheld, dosage reduced, or permanently discontinued based on the severity of adverse reactions.

  • Biological E Covid-19 Vaccine receives DCGI approval for Two Clinical Trials

    The Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India (GoI) has taken myriads of initiatives to increase investments in research & development (R&D) and manufacturing of COVID-19 Vaccines.

  • Zycov-D, needle free COVID vaccine in the world is approved in India

    Zydus Cadila announced that the company has received the Emergency Use Authorization from the Drug Controller General of India (DCGI) for ZyCoV-D the worlds first Plasmid DNA Vaccine for COVID-19. ZyCoV-D is a three dose vaccine which will be administered first on day zero, day 28th and then on the 56th day. With this approval, India now has its first COVID-19 vaccine for the adolescents in the 12-18 age group, besides the adult population.

  • Novavax submits Recombinant COVID-19 Vaccine for approval in India

    Novavax, Inc a biotechnology company developing next-generation vaccines for serious infectious diseases, with its partner, Serum Institute of India Pvt. Ltd announced that the companies have filed regulatory submissions for emergency use authorization of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. The submissions were made to the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines.

  • BDR Pharma gets license pact with DRDO for 2-DG

    BDR Pharma gets license pact with the Defence Research and Development Organisation (DRDO) to manufacture, distribute, and market COVID-19 drug 2-Deoxy-D-Glucose (2-DG) in the country.

    Last month, the Drugs Controller General of India (DCGI) had approved the oral medication for emergency usage as adjuvant therapy in mild to severe COVID-19 patients.

  • Anti-COVID drug Colchicine cleared for phase 2 clinical trials

    Council of Scientific & Industrial Research (CSIR), and Laxai Life Sciences Pvt. Ltd., Hyderabad, have been given the regulatory approval by the Drugs Controller General of India (DCGI) to undertake a two-arm phase-II clinical trial to assess the safety and efficacy of the drug Colchicine in the improvement of clinical outcomes during the treatment of COVID-19 patients.

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