Serum Institute applies for EUA for Covishield in India
According to sources, this vaccine is logistically feasible for distribution in the country's both urban and rural parts as it can…
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DCGI
Pfizer seeks EUA for COVID-19 vaccine in India
It is the first company to seek approval for its vaccine in India
Zydus gets DCGI approval to commence Phase III clinical trials with Pegylated Interferon alpha-2b
In Phase II clinical trials, Pegylated Interferon alpha – 2b increased viral reduction and reduced the need for supplemental…
SEC asks Biocon to submit safety, mortality data for Itolizumab
The company claims that approximately 2000 COVID-19 patients used the drug under the emergency use authorisation
DCGI finds no linkage between Covishield shot and volunteer’s adverse event during trial
An expert committee recommended that compensation should not be paid to the subject or legal heir/nominee of the subject
Experts question continuation of Covishield vaccine trials in India despite adverse event report
Censure SII’s move to file a defamation suit on the participant who reported the adverse event, stating that it will discourage…
DCGI asks state drug controllers to recall ulipristal acetate tablets from market
The decision is based on the PRAC recommendations and reported cases of liver injury in the EU
Industry experts disagree with NPPA’s remark on FDCs
Experts say it is beyond the jurisdiction of NPPA
Experts seek data on remdesivir and COVID-19 treatment-related products
Ask for details of specific indications for which approval has been granted, any conditions or restrictions attached to the…
Bharat Biotech plans Covaxin launch in second quarter of 2021, post requisite approvals
Immediate focus is to conduct Phase 3 trial successfully