Wednesday, May 25, 2022
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FDA Lifts Hold On Covaxin's Clinical Trials In US

FDA Lifts Hold On Covaxin's Clinical Trials In US

FDA had earlier implemented a temporary pause on Covaxin trials, following the WHO's observations on Covaxin manufacturing plants in India.

24 May 2022
Alembic Pharmaceuticals Gets USFDA Nod To Market Generic Tablet For Atrial Fibrillation

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...

10 January 2022

Alembic Pharma Gets USFDA Approval For Generic Drug

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...

PM Calls Retired Lt Gen Hooda, Assures That His Ailing Sister's Request On New Breast Cancer Drug Will Be Considered

PM Calls Retired Lt Gen Hooda, Assures That His Ailing Sister's Request On New Breast Cancer Drug Will Be Considered

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...

19 December 2021

Bharat Biotech’s US Partner Seeks Approval For Use Of Covaxin In Children

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.

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27 October 2021
US: 5 To 11-Year-Old Kids May Get Covid-19 Vaccine Soon As FDA Panel Endorses Pfizer Shots

US: 5 To 11-Year-Old Kids May Get Covid-19 Vaccine Soon As FDA Panel Endorses Pfizer Shots

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...


23 October 2021
Pfizer Covid-19 Vaccine Effective For Kids: FDA

Pfizer Covid-19 Vaccine Effective For Kids: FDA

As per FDA scientists, Pfizer vaccine's benefit for preventing hospitalisations and death from Covid-19 would outweigh any serious potential side effects in...


16 October 2021
FDA Panel Endorses Booster Shot For J&J COVID-19 Vaccine

FDA Panel Endorses Booster Shot For J&J COVID-19 Vaccine

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...


14 October 2021
FDA Panel Debates Lower-Dose Moderna COVID Shots For Booster

FDA Panel Debates Lower-Dose Moderna COVID Shots For Booster

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...


07 October 2021
Pfizer Urges US Govt To Allow Covid-19 Shots For Kids Of 5 To 11 Years Age

Pfizer Urges US Govt To Allow Covid-19 Shots For Kids Of 5 To 11 Years Age

Pfizer announced in a tweet that it had formally filed its application with the Food and Drug Administration.


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23 September 2021
US Approves Booster Dose Of Pfizer's Covid-19 Vaccine For Special Groups

US Approves Booster Dose Of Pfizer's Covid-19 Vaccine For Special Groups

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...


18 September 2021
Top Doctors Say Not So Fast To Biden's Boosters-For-All Plan

Top Doctors Say Not So Fast To Biden's Boosters-For-All Plan

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...


17 September 2021
Covid-19: US Approves New Use Of Eli Lilly's Drug For Treating Patients

Covid-19: US Approves New Use Of Eli Lilly's Drug For Treating Patients

Before this approval, this drug was only used for people who were confirmed with Covid-19 and were categorized as high-risk ones.


09 September 2021
Zydus Cadila Gets USFDA Nod For Schizophrenia Treatment Drug

Zydus Cadila Gets USFDA Nod For Schizophrenia Treatment Drug

The company said that it would manufacture the drug at its manufacturing facility at the SEZ, Ahmedabad.


24 August 2021
Anthony Fauci Expects Uptick In Vaccination Following FDA's  Approval Of Pfizer Vaccine

Anthony Fauci Expects Uptick In Vaccination Following FDA's Approval Of Pfizer Vaccine

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...


18 August 2021
US Approves Booster Shots To Tackle Decline In Vaccine Efficacy

US Approves Booster Shots To Tackle Decline In Vaccine Efficacy

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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17 August 2021
US May Recommend Boosters Eight Months After Second Covid Vaccine Dose

US May Recommend Boosters Eight Months After Second Covid Vaccine Dose

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.


13 August 2021
FDA Authorises Extra COVID Vaccines For Those With Weak Immunities

FDA Authorises Extra COVID Vaccines For Those With Weak Immunities

The announcement came on Thursday, by the Food and Drug Administration which applies to several million Americans who are especially vulnerable because of...


10 August 2021
Pentagon Makes Covid-19 Vaccines Compulsory For US Military Members Under New US Plan

Pentagon Makes Covid-19 Vaccines Compulsory For US Military Members Under New US Plan

Defense Secretary Lloyd Austin said the mid-September deadline could be accelerated if the vaccine receives final FDA approval or infection rates continue to...


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