US FDA-Gujarat FDCA Regulatory Forum to be held from 17th to 19th May
In this meeting, 12 officials from the US FDA, senior officers from Gujarat FDCA and four drug officers nominated by Drugs…
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US FDA
FDA declines to authorise common antidepressant as COVID treatment
The generic drug belongs to an old, widely-used class of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs)
Moderna completes FDA submission for use of COVID shot in adolescents, kids
The company is seeking approval for the use of its vaccines in three distinct age groups - adolescents aged 12 to 17 years,…
Sun Pharma gets Form 483 from US FDA for regulatory violations at Halol plant
The US Food and Drug Administration (FDA) conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from…
Novavax files for authorisation of COVID-19 shot among adolescents in Britain
The drugmaker in late January filed for Emergency Use Authorisation (EUA) of its COVID-19 shot for adults in the US
US FDA declines to approve two more China-tested drugs
The decisions could add pressure on Chinese stocks, especially biotech companies, at a time shares of several US-listed Chinese…
Aurobindo and Sun Pharma recall products in US market
While Aurobindo Pharma is recalling Cyanocobalamin injection, Sun Pharma is recalling a drug used to increase the production of…
FDA lifts partial clinical hold on Gilead’s blood cancer drug trials
The health regulator had placed the hold on five cancer trials in January due to an imbalance in suspected and unexpected serious…
Lupin receives US FDA approval for Sildenafil for oral suspension
The product will be manufactured at Lupin’s facility in Goa
US FDA declines to approve AstraZeneca treatment for chronic nasal condition
The drugmaker said the US Food and Drug Administration (FDA) had issued a complete response letter following AstraZeneca's…