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Food and Drug Administration (FDA)

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

Jan 10, 2022 Press Trust of India

The company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its medication in the strength of 400 mg.

Alembic Pharma Gets USFDA Approval For Generic Drug

Jan 04, 2022 Press Trust of India

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 International Pty Ltd (Mayne).


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 the drug Trodelvy for the Indian market as it would grant her and several others a "lease of life".

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

Nov 05, 2021 Outlook Web Desk

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.


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 to decide whether to recommend the shots and which youngsters should get them.

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23 October, 2021

Pfizer Covid-19 Vaccine Effective For Kids: FDA

Associated Press (AP)

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


16 October, 2021

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

Associated Press (AP)

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 work better if people wait until six months later.


14 October, 2021

FDA Panel Debates Lower-Dose Moderna COVID Shots For Booster

Associated Press (AP)

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 extra-contagious delta variant of the coronavirus has burned across the country.


07 October, 2021

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

Associated Press (AP)

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


23 September, 2021

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

Associated Press (AP)

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 doses. Food And Drug Administration(FDA) gives approval.


18 September, 2021

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

Associated Press (AP)

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 dose only for those who are age 65 or older or who run a high risk of severe disease.


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17 September, 2021

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

Associated Press (AP)

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

Outlook Web Desk

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

Associated Press (AP)

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 reason for not getting vaccinated


18 August, 2021

US Approves Booster Shots To Tackle Decline In Vaccine Efficacy

Outlook Web Desk

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 people get their second shot of the Pfizer or Moderna vaccine.


17 August, 2021

US May Recommend Boosters Eight Months After Second Covid Vaccine Dose

Associated Press (AP)

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

Associated Press (AP)

The announcement came on Thursday, by the Food and Drug Administration which applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers, or other disorders.


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10 August, 2021

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

Associated Press (AP)

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


Photo Gallery

A farmer sits near his red chillies at a deserted APMC market, during the weekend curfew imposed by the Karnataka government to curb the spread of COVID-19, in Hubballi.

PTI Photo

Delhi Chief Minister & AAP National Convenor Arvind Kejriwal being welcomed by women supporters during his door-to-door campaign ahead of the Goa Assembly elections, in Goa.

PTI Photo

A health worker collects swab sample of a woman for COVID-19 test, amid concerns over rising Omicron cases, in Gurugram.

PTI Photo

Traffic jam on a road at Shalimar Bagh during the weekend curfew imposed by the Delhi government to curb the spread of Covid-19, in New Delhi.

PTI Photo/ Shahbaz Khan

The Lajpat Nagar market wears a deserted look during the weekend curfew imposed by the Delhi government to curb the spread of Covid-19, in New Delhi.

PTI Photo/ Shahbaz Khan
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Short Story

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Graphic Novel

Play Us A Memory, Violin Man

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Fact-Check

It’s Just Numbers, Love

Younger people do not have much progressive beliefs; a 2017 survey found that one-third of young people opposed inter-caste marriage.

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Opinion

The Future of Universities: Can India Overcome The Digital Divide?

The pandemic has made it clear that virtual learning is here to stay. In the West, the big question is whether it will dilute the quality of the college experience and education. In India, which grapples with digital divide, the question remains whether this will reach most people at all.

Jan 15, 2022 Saikat Majumdar

Super Immunity, Natural Vaccines, Covid Gods: A Desi Guide To Denying The Pandemic

Even after two years of the Covid-19 pandemic, many 'informed' individuals in India continue to deny the virus with unscientific claims and unfounded data. The latest? Omicron will end the pandemic.

Jan 08, 2022 Rakhi Bose

What Is The Future Of The Liberal Arts In Asia?

Across Asia there are deeply entrenched obstacles to a mode of higher education that is liberal in multiple senses – disciplinary and epistemological but also social and political.

Jan 01, 2022 Saikat Majumdar

Nagaland To Lakhimpur Kheri: Rights, Regimes And Restitutions in Times Of Turbulence

The two incidents in the recent past, one in Mon district of Nagaland and the other at Lakhimpur Kheri in Uttar Pradesh, undermined the core principles democracy and federalism.

Dec 28, 2021 Tanvir Aeijaz