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"dcgi"

  • 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 […]
  • Phase 2,3 trial data of India’s first mRNA COVID vaccine submitted to DCGI

    New Delhi: Pune-based Gennova Biopharmaceuticals has submitted the phase-II and phase-III trials data of India’s first mRNA COVID vaccine to the regulator Drugs Controller General of India (DCGI) on Friday, said sources. The company has also developed an Omicron-specific vaccine which will be tested on humans for efficacy and immunogenicity. Earlier the DG, Indian Council […]
  • DCGI approves Themis Medicare’s VIRALEX® for Covid-19 treatment

    Viralex® has been found to be effective and well tolerated in mild to moderate COVID-19, in two Randomized Controlled Clinical Trials conducted on 499 Indian patients.
  • DCGI grants approval to single-shot Sputnik Light for emergency use: Dr Reddy’s

    Sputnik Light is a one-dose vaccine and the same as the first component— recombinant human adenovirus serotype number 26 (rAd26) — of the two-dose Sputnik V vaccine, Dr Reddy's said in a statement.
  • Bharat Biotech gets DCGI’s nod to conduct intranasal booster dose trials

    The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had also recommended the internasal vaccine clinical trials during the last meeting.
  • SEC to hold meeting on Bharat Biotech’s Nasal vaccine booster dose

    New Delhi: The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) is expected to meet on Tuesday afternoon to discuss Bharat Biotech’s application for clinical trials of its intranasal Covid vaccine as a booster or a third dose. The Hyderabad-based manufacturer has proposed the booster dose for those who have been […]
  • Covaxin gets DCGI nod for emergency use in children aged 12-18 years

    Hyderabad: Bharat Biotech on Saturday said it received DCGI approval for emergency use of Covaxin for children aged 12-18 years. The vaccine has established a proven record for safety and efficacy in adults for the original variant and subsequent variants. “We have documented excellent safety and immunogenicity data readouts in children. We look forward for […]
  • MSN Group launches anti-epileptic drug for infants

    Hyderabad: Hyderabad-based MSN Labs has launched anti-epileptic drug, India’s first generic vigabatrin powder for oral solution under the brand name Viganext. An infantile spasm is a seizure with sudden stiffening of the body and brief bending forward or backward of the arms, legs and head. Vigabatrin is recommended as the first-line therapy for infantile spasm, […]
  • Hyderabad offers key inputs for oral Covid drug

    Hyderabad: The much-awaited first oral medication for Covid-19 based on Molnupiravir is expected to hit the shelves of drug stores in the coming months. While the oral pill has received lot of attention for its therapeutic promise in reducing hospital stay and death risk among Covid patients, the fact remains that Hyderabad, due to its […]
  • Dr Reddy’s hopes to submit Sputnik V Light trial data to DCGI next month

    Hyderabad: Hyderabad-based pharmaceutical company Dr Reddy’s on Friday said it hopes to submit phase 3 trial data of Sputnik V Light, the single dose vaccine, to the Drugs Controller General of India (DCGI) next month. The company is also starting trials on children in two cohorts involving children of the age groups of 2-12 years […]
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