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US FDA

News and updates about US FDA

First Neuralink chip implanted in human

Elon Musk, who owns Neuralink, says the project is intended to allow quadriplegics to move their limbs, and eventually to expand to controlling computers by thought.

First Neuralink chip implanted in human

What really happened to the Neuralink monkeys?

A new report claims that the monkeys used in Elon Musk's brain implant trials were not all unharmed - as the billionaire claimed.

What really happened to the Neuralink monkeys?

FDA approves updated COVID-19 vaccines

Food and Drug Administration gives green light to updated COVID-19 vaccines from Moderna and Pfizer/BioNTech.

FDA approves updated COVID-19 vaccines

FDA grants full approval to Alzheimer's drug

Food and Drug Administration approves the drug Leqembi, proven to slow the course of Alzheimer's.

FDA grants full approval to Alzheimer's drug

FDA approves updated COVID vaccines for children under 5

Food and Drug Administration clears doses of updated COVID-19 vaccines for children younger than age 5.

FDA approves updated COVID vaccines for children under 5

FDA warns of shortage of common antibiotic used for kids

Amoxicillin placed on lists of drugs in short supply as FDA warns of nationwide shortage of most widely used antibiotic in the US.

FDA warns of shortage of common antibiotic used for kids

US authorizes updated boosters for children as young as five

FDA and CDC both approve tweaked boosters, one made by Pfizer for 5- to 11-year-olds, and a Moderna version for those as young as 6.

US authorizes updated boosters for children as young as five

Pfizer seeks US approval of vaccine targeting Omicron

Pfizer submits application to FDA for an updated COVID-19 vaccine targeting the Omicron subvariant.

Pfizer seeks US approval of vaccine targeting Omicron

FDA authorizes COVID-19 shots for infants

Food and Drug Administration authorizes Pfizer and Moderna shots for children under 5. Vaccinations could begin next week.

FDA authorizes COVID-19 shots for infants

FDA advisers back COVID vaccine for children under 5

Food and Drug Administration's vaccine advisers approve Moderna and Pfizer’s COVID-19 vaccine for infants, toddlers and preschoolers.

FDA advisers back COVID vaccine for children under 5

Pfizer seeks FDA approval for boosters for children

Pfizer and BioNTech submits application to FDA requesting authorization to administer booster dose to children aged 5-11.

Pfizer seeks FDA approval for boosters for children

Moderna seeks authorization for fourth booster

Moderna asks FDA to authorize fourth shot of its COVID-19 vaccine as booster dose for all adults.

Moderna seeks authorization for fourth booster

A look at Pfizer documents released by FDA following court order

Dr. John Campbell analyzes Pfizer data used by FDA to license COVID shot, detailing adverse effects in first months of its use.

A look at Pfizer documents released by FDA following court order

FDA official: Plans for annual COVID shot, shots for toddlers

James O'Keefe speaks to Hannity on Project Veritas exposé revealing future plans for COVID shots and FDA ties to pharmaceutical companies.

FDA official: Plans for annual COVID shot, shots for toddlers

High-level FDA official reveals ties between agency and pharma

Project Veritas talks with FDA executive who says 'almost a billion dollars a year going into FDA's budget from the people we regulate.'

High-level FDA official reveals ties between agency and pharma

Pfizer postpones FDA request for vaccine for kids under 5

Pfizer-BioNTech postponing application to expand use of its COVID-19 vaccine for children under age 5.

Pfizer postpones FDA request for vaccine for kids under 5

US to roll out vaccines for children under 5 later this month

US government planning to roll out Pfizer COVID-19 vaccines for children under age of 5 as soon as February 21.

US to roll out vaccines for children under 5 later this month

Pfizer seeks US approval of vaccine for children under 5

Pfizer and BioNTech officially announce they are seeking emergency use authorization of their COVID-19 vaccine for children under age 5.

Pfizer seeks US approval of vaccine for children under 5

Pfizer to ask FDA to approve vaccine for children 0-5

Pfizer, BioNTech, expected to request emergency use authorization for 2-dose COVID-19 vaccine series for children 6 months to 5 years.

Pfizer to ask FDA to approve vaccine for children 0-5

Novavax asks FDA to authorize its COVID-19 vaccine

Novavax files for emergency use authorization of its COVID-19 vaccine for US adults.

Novavax asks FDA to authorize its COVID-19 vaccine

Court rules FDA must accelerate release of Pfizer documents

US district judge rules FDA must produce 55,000 pages of Pfizer data per month, rejecting FDA request to produce only 500 pages per month.

Court rules FDA must accelerate release of Pfizer documents

FDA approves Pfizer boosters for teens

Children between ages of 12-15 now eligible to receive 3rd doses of COVID vaccines in US.

FDA approves Pfizer boosters for teens

FDA approves Swiss company's rapid COVID test

FDA grants emergency use authorization for Swiss company Roche's at-home COVID-19 test.

FDA approves Swiss company's rapid COVID test

FDA authorizes Pfizer's COVID-19 pill

Pfizer says the drug, administered in a pill called Paxlovid, reduces risk of hospitalization and death by up to 90%.

FDA authorizes Pfizer's COVID-19 pill

FDA authorizes AstraZeneca's COVID-19 antibody cocktail

FDA authorizes AstraZeneca's antibody cocktail for individuals with immune systems or history of side effects from coronavirus vaccines.

FDA authorizes AstraZeneca's COVID-19 antibody cocktail

FDA panel backs Merck's COVID-19 pill

FDA advisory committee recommends emergency authorization of Merck’s experimental drug to treat COVID-19.

FDA panel backs Merck's COVID-19 pill

Moderna asks FDA to authorize booster for all adults

Moderna applies with Food and Drug Administration for authorization of its COVID-19 booster vaccine for all adults aged 18 and older.

Moderna asks FDA to authorize booster for all adults

Pfizer Tests: All-cause mortality higher among the vaccinated

FDA report shows Pfizer's clinical trials found 24% higher all-cause mortality rate among the vaccinated compared to placebo group.

Pfizer Tests: All-cause mortality higher among the vaccinated

FDA could authorize boosters for all adults as early as Thursday

FDA aiming to authorize Pfizer booster doses for all adults as early as Thursday, sources say.

FDA could authorize boosters for all adults as early as Thursday

Moderna says FDA will need more time to assess vaccine for teens

FDA says it will require additional time to complete its assessment of Moderna's COVID-19 vaccine for use in adolescents.

Moderna says FDA will need more time to assess vaccine for teens

FDA approves Pfizer vaccine for children aged 5-11

Pfizer and BioNTech’s COVID-19 vaccine receives FDA authorization for children ages 5 to 11, days after experts panel recommended it.

FDA approves Pfizer vaccine for children aged 5-11

FDA panel recommends COVID-19 vaccine for 5-to-11-year-olds

US Food and Drug Administration advisers endorse Pfizer’s COVID-19 vaccine for children ages 5 to 11.

FDA panel recommends COVID-19 vaccine for 5-to-11-year-olds

'FDA is expected to approve COVID vaccine for young children'

Israel's public health chief says FDA is likely to clear Pfizer's COVID vaccine for use among children ages 5-11.

'FDA is expected to approve COVID vaccine for young children'

Fauci: Children could receive their vaccine in early November

Biden's chief medical adviser estimates that children ages 5 to 11 may be able to receive vaccine in the first two weeks of November.

Fauci: Children could receive their vaccine in early November

FDA authorizes Moderna, J&J booster shots

Regulator also approves “mix and match” method, allows people to choose different shot than their original inoculation as a booster.

FDA authorizes Moderna, J&J booster shots

Report: FDA to permit 'mixing and matching' of booster shots

FDA planning to allow Americans to get a different booster shot of COVID-19 vaccine than the one they initially took, sources say.

Report: FDA to permit 'mixing and matching' of booster shots

FDA delaying decision on Moderna vaccine for adolescents

FDA delaying decision on authorizing Moderna's COVID-19 vaccine for adolescents.

FDA delaying decision on Moderna vaccine for adolescents

FDA advisers recommend Johnson & Johnson's booster shot

Outside advisers to Food and Drug Administration vote unanimously to recommend a second shot of Johnson & Johnson's COVID-19 vaccine.

FDA advisers recommend Johnson & Johnson's booster shot

FDA panel recommends Moderna booster

Panel of expert advisers to FDA votes 19-0 to recommend booster shots of Moderna's COVID-19 vaccine for Americans aged 65 and older.

FDA panel recommends Moderna booster

FDA scientists: Moderna did not meet all criteria for boosters

Scientists at FDA say Moderna has not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine.

FDA scientists: Moderna did not meet all criteria for boosters

FDA panel to review COVID vaccines for children

FDA panel to discuss booster doses of Moderna and Johnson & Johnson vaccines and clearing Pfizer's vaccine for use in children.

FDA panel to review COVID vaccines for children

FDA authorizes booster shots for ages 65 and older

FDA authorizes booster doses for Americans aged 65 and older and younger adults with underlying health conditions.

FDA authorizes booster shots for ages 65 and older

'We won't vaccinate children without FDA approval'

Approval of a booster dose isn't the same as vaccinating children without FDA approval, Health Ministry's Dr. Sharon Alroy-Preis says.

'We won't vaccinate children without FDA approval'

Did the FDA's chaotic booster dose add to Americans' fears?

With US experts expressing doubt over a third dose for younger males but allowing it for adults, existing uncertainties likely to increase.

Did the FDA's chaotic booster dose add to Americans' fears?

FDA panel rejects COVID-19 booster shots for most Americans

FDA committee rejects COVID-19 booster shots for Americans aged 16 and over, but approves boosters for 65+ and high risk individuals.

FDA panel rejects COVID-19 booster shots for most Americans

Pfizer recommends COVID vaccine booster shots

FDA releases documents showing Pfizer recommending administration of 3rd vaccine dose due to declining effectiveness of 1st doses.

Pfizer recommends COVID vaccine booster shots

Pfizer seeks US approval of booster dose of its COVID-19 vaccine

Pfizer says it has started the application process for a third dose of its vaccine for everyone ages 16 and older.

Pfizer seeks US approval of booster dose of its COVID-19 vaccine

Report: FDA to approve booster shots within 48 hours

Sources say FDA will authorize COVID-19 vaccine booster shots for some people who are immunocompromised.

Report: FDA to approve booster shots within 48 hours

FDA could give full approval for Pfizer vaccine by September

Officials say FDA is aiming to give full approval for the Pfizer COVID-19 vaccine by early September.

FDA could give full approval for Pfizer vaccine by September

FDA could authorize vaccines for children in midwinter

Emergency authorization for COVID-19 vaccines in children under 12 could come in early to midwinter, says FDA official.

FDA could authorize vaccines for children in midwinter

FDA adds new warning on Johnson & Johnson vaccine

FDA says Johnson & Johnson coronavirus vaccine is linked to Guillain-Barré syndrome.

FDA adds new warning on Johnson & Johnson vaccine

FDA: Millions of J&J vaccines from troubled plant can't be used

FDA informs Johnson & Johnson that millions of vaccine doses produced at troubled Baltimore plant can't be used due to contamination issues.

FDA: Millions of J&J vaccines from troubled plant can't be used

FDA authorizes antibody treatment for COVID-19

FDA gives emergency use authorization to Sotrovimab for treating mild-to-moderate COVID-19 in people aged 12 years and older.

FDA authorizes antibody treatment for COVID-19

Watch: America begins vaccinating 12-15-year-olds

The campaign is to go national following FDA approval.

Watch: America begins vaccinating 12-15-year-olds

FDA authorizes Pfizer vaccine for 12–15-year-olds

Food and Drug Administration lowers the age that people can receive Pfizer's vaccine in the US to 12.

FDA authorizes Pfizer vaccine for 12–15-year-olds

Report: FDA to approve Pfizer vaccines for adolescents

Federal officials say FDA could authorize Pfizer vaccine in adolescents 12 to 15 years old by early next week.

Report: FDA to approve Pfizer vaccines for adolescents

Pfizer seeks FDA approval to vaccinate adolescents

Pfizer asks Food and Drug Administration to expand the emergency use of COVID-19 vaccine in adolescents aged 12 to 15.

Pfizer seeks FDA approval to vaccinate adolescents

FDA approves Johnson & Johnson COVID-19 vaccine

FDA says J&J's vaccine offers strong protection against serious illness, hospitalizations and death.

FDA approves Johnson & Johnson COVID-19 vaccine

FDA approves standard freezing temperatures for Pfizer vaccines

Food and Drug Administration approves storage and transportation of Pfizer vaccine at standard freezer temperatures.

FDA approves standard freezing temperatures for Pfizer vaccines

FDA: Johnson & Johnson vaccine meets standard for emergency use

Vaccine found to have 66% effectiveness against moderate and severe COVID cases, no safety concerns.

FDA: Johnson & Johnson vaccine meets standard for emergency use