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FDA News

23 Feb 2024

Maharashtra FDA Exposes McDonald's For Alleged Food Quality Concerns

Maharashtra FDA Commissioner Abhimanyu Kale stated that they received customer feedback regarding the use of cheese analogues instead of real cheese.

11 Feb 2023

Sun Pharma Recalls Over 34k Bottles of defective Generic Drug in US

The Mumbai-based drug major had produced the lot at its Halol-based manufacturing facility in Gujarat. The affected lot was later distributed in the market by its US-based unit.

06 May 2022

US FDA limits use of Johnson & Johnson Covid-19 vaccine over blood clot risk

The Johnson and Johnson vaccine was authorised for emergency use in February last year. As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that were fatal. FDA said the shot should only be given to adults who cannot receive a different vaccine.

15 Apr 2022

InspectIR: FDA authorizes 1st breath test for Covid-19 infection in US

The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.

18 Mar 2022

Moderna seeks FDA approval for fourth Covid vaccine to be used as booster shot

Moderna is now seeking Food and Drug Administration (FDA) approval for its fourth shot of the Covid-19 vaccine to be administered as a booster dose in eligible adults.

11 Jan 2022

Molnupiravir benefits outweigh risk among Covid patients: Experts

An expert panel of the Central Drugs Standard Control Organisation had recently approved the antiviral Molnupiravir for restricted use in emergency situations, However, ICMR has raised concern over its side effects.

09 Dec 2021

US clears AstraZeneca antibody for treating cases of COVID-19 infections

The AstraZeneca antibody-drug cleared by the US Food and Drug Administration on Wednesday is different. It's the first authorised for long-term prevention against COVID-19 infection, rather than short-term treatment.

06 Nov 2021

Covaxin for kids: Bharat Biotech's partner requests approval in the US

Pfizer's shot is the only approved COVID jab for children under 18 in US Bharat Biotech's Covaxin got WHO nod for emergence use listing recently Vaccination is the most important step, say experts, in combating the pandemic

27 Oct 2021

US backs Pfizer's low-dose COVID-19 vaccine for kids, FDA approval likely

A Food and Drug Administration advisory panel voted unanimously, with one abstention, that the vaccine's benefits in preventing COVID-19 in that age group outweigh any potential risks including a heart-related side effect that's been very rare in teens and young adults despite their use of a much higher shot dose.

21 Oct 2021

US approves new booster of COVID-19 vaccines, mix and match dose

FDA approved the use of third doses of Moderna and Johnson & Johnson vaccines. FDA also approved "mix and match" booster doses.

23 Sep 2021

FDA approves booster shots of Pfizer COVID-19 vaccine for older Americans

The booster dose is to be administered at least six months after completion of the second dose, and the authorization would include people most susceptible to severe disease and those in jobs that left them at risk, the FDA said.

30 Aug 2021

'Pfizer COVID vaccine may be authorised for 5-year-olds by October'

Pfizer COVID vaccine may be authorised for 5-year-olds by October Pfizer, Moderna and Johnson and Johnson are conducting clinical trials to evaluate the safety and efficacy of the vaccines in children under 12 Results of the Pfizer vaccine for children are expected in September.

27 Jun 2021

US FDA okays arthritis drug for treatment of COVID-19

The drug Actemra (tocilizumab), which is used for arthritis can be given to hospitalised COVID-19 patients in the USA However, Actemra is not authorised for use in outpatients with COVID-19

11 Jun 2021

FDA rejects emergency approval for Covaxin in a setback for India-made jab

FDA has told the the US partner of the Indian vaccine maker to go for Biologics Licence Application route The development may delay the Covaxin launch in the US The company will pursue expedited authorisation for the vaccine in Canada

05 May 2021

COVID jabs for kids aged 2 to 11: Pfizer to seek approval in Sept

Pfizer to seek FDA emergency authorisation to administer its coronavirus vaccine among children between the ages of 2 and 11 in September Pfizer is already expected to get FDA approval for emergency use of its vaccine in children 12 to 15 years old

04 May 2021

US FDA to authorise Pfizer jabs for 12 to 15-year-old by next week

FDA approves use of Pfizer-BioNTech coronavirus vaccine for adolescents aged 12 to 15 years Vaccinating adolescents may also be key to boost immunity levels in the general population

03 May 2021

COVID oral pill could be ready by year-end: Pfizer CEO

COVID pills could be ready by the end of 2021 The pills are protease inhibitors and works by inhibiting an enzyme that the virus needs to replicate in human cells Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C

12 Dec 2020

US FDA authorizes Pfizer's COVID-19 vaccine for emergency use

US FDA has authorized Pfizer's COVID-19 vaccine for emergency use President Donald Trump has promised the first immunizations would take place "in less than 24 hours."

04 Dec 2020

3 former US presidents willing to take COVID-19 vaccine publicly

3 former US presidents are willing to take COVID-19 vaccine publicly to boost confidence Former President Barack Obama has said this in a TV show former President Bill Clinton and George Bush have expressed willingness to get a vaccine on camera

02 May 2020

US regulator FDA allows emergency use of remdesivir drug for COVID-19 patients

US regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster.

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