FDA had earlier implemented a temporary pause on Covaxin trials, following the WHO's observations on Covaxin manufacturing plants in India.
.jpg "Alembic Pharmaceuticals Gets USFDA Nod To Market Generic Tablet For Atrial Fibrillation")
The company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its medication...
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Doryx Tablets, 75 mg, 100 mg, 150 mg, and 200 mg, of Mayne Pharma...
On Saturday afternoon, Sushma Hooda tweeted that she is requesting the prime minister "with great hope" to intervene and ensure early approval and purchase of...
The submission is based on results of Bharat Biotech's Phase 2/3 paediatric clinical trial involving 526 children between 2-18 years of age.
If the US Food and Drugs Administration (FDA) authorises the kid-size Covid-19 vaccination doses now, the Centers for Disease Control and Prevention will have...
As per FDA scientists, Pfizer vaccine's benefit for preventing hospitalisations and death from Covid-19 would outweigh any serious potential side effects in...
J&J told the Food and Drug Administration that an extra dose adds important protection as early as two months after initial vaccination — but that it might...
U.S. officials stress that the priority is to get shots to the 66 million unvaccinated Americans who are eligible for immunization -- those most at risk as the...
Pfizer announced in a tweet that it had formally filed its application with the Food and Drug Administration.
People over 65 years of age, Young adults with underlying health conditions and people whose jobs put them at high Covid-19 infection risk to get booster...
A key government advisory panel overwhelmingly rejected Biden's plan to give COVID-19 booster shots across the board and instead recommended the extra vaccine...
Before this approval, this drug was only used for people who were confirmed with Covid-19 and were categorized as high-risk ones.
The company said that it would manufacture the drug at its manufacturing facility at the SEZ, Ahmedabad.
The top infectious disease expert in the U.S. says the Food and Drug Administration's decision Monday should encourage people who cited lack of approval as a...
The plan, as outlined by the director of the Centers for Disease Control and Prevention and other top authorities, calls for an extra dose eight months after...
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The action is expected for the Pfizer shot in the coming weeks. However, the Food and Drug Administration is yet to formally approve the vaccine.
The announcement came on Thursday, by the Food and Drug Administration which applies to several million Americans who are especially vulnerable because of...
Defense Secretary Lloyd Austin said the mid-September deadline could be accelerated if the vaccine receives final FDA approval or infection rates continue to...