EMA authorises Pfizer covid vaccine “Comirnaty” for 12-15 yrs
EMA has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15.... Read More
ViiV Healthcare’s Rukobia received EMA marketing authorisation
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc and Shionogi Limited as shareholders, announced... Read More
Sanofi received additional indication approval for Plavix
European Commission (EC) has approved an additional indication for Plavix (clopidogrel) to include its use in combination with aspirin in adult patients... Read More
Covid 19 Vaccine development and commercialization status | More than 50 vaccine candidate under development
Posted on28 Nov 2020
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More than 50 covid-19 vaccine candidate is currently under development. Here you can have the close look into the development status of... Read More
US FDA grants priority review status to Sanofi’s BLA for avalglucosidase alfa to treat Pompe disease
The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa for long-term... Read More
Case Study: Compassionate use of remdesivir of Gilead for COVID-19
Posted on06 Apr 2020
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During an extraordinary virtual meeting held on April 2, 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral... Read More
Gilead’s Epclusa receives US FDA approval to treat chronic hepatitis C infection for children ages 6 & older
US FDA has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment... Read More
Bayer received EU marketing authorization for the precision oncology treatment Vitrakvi (larotrectinib)
Bayer announced that the European Commission has granted marketing authorization in the European Union (EU) for the precision oncology treatment Vitrakvi (larotrectinib).... Read More
Take a Self Competency Test in European Drug Regulatory Affairs
Posted on07 Aug 2019
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Effective regulatory strategic planning is a challenging as different regions and countries need to follow different regulatory requirements for Marketing Authorization Application... Read More
How data integrity related problems should be addressed in Pharmaceutical and Biopharmaceutical Industry?
Drug Regulatory Body encourages to demonstrate that organization have effectively remediated problems by investigating to determine the problem’s scope and root causes,... Read More