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FDA APPROVAL MODERNA
Moderna says FDA will consider new flu shot after resolving public disputeThe FDA will now consider Moderna's mRNA flu vaccine application after a dispute over clinical trial design. Moderna agreed to seek full ap...- US FDA reverses course, will review Moderna's revised flu vaccine applicationThe US Food and Drug Administration will now review Moderna's influenza vaccine. This comes after an initial refusal due to trial design is...
- US FDA approves Moderna's next-gen COVID vaccine for adults 65 or olderModerna's updated COVID-19 vaccine has received FDA approval for individuals aged 65 and older, marking the first endorsement under stricte...
- Moderna pulls application for COVID-flu combination shotModerna has withdrawn its application for a combination flu and COVID vaccine, awaiting efficacy data from a late-stage influenza shot tria...
- Vaccine maker Moderna forecasts lower sales next year, shares tumble 17% to near four-year lowModerna has delayed its break-even goal by two years, pushing it to 2028, due to slower regulatory processes for key products like flu and ...
- Moderna seeks US FDA approval for Omicron Covid booster for children over 6 yearsIn a request to the Food and Drug Administration (FDA), Boston-based biotech has requested that omicron shots be approved for teenagers age...
- U.S. FDA reviews Pfizer & Moderna Covid 19 vaccines in young childrenUS health experts' panel will be reviewing the use of covid vaccines in young children on Wednesday. If the committee recommends using covi...
- Moderna seeks FDA approvals for its vaccine for kids under 6Now that kids under 6 are the only strata of population that still does not have a vaccine, this move by Moderna might just be the final pi...
- Key data on US J&J, Moderna COVID-19 boosters 'weeks away,' Fauci saysU.S. health regulators already have begun to consider a third dose of the Pfizer/BioNTech vaccine.
- Pfizer booster shot may start in US by September 20: Anthony FauciThe rollout for Moderna's booster vaccine could, however, be delayed, CNBC news quoted Anthony Fauci as saying on Sunday. Although both dru...
- US regulators give full approval to Pfizer COVID-19 vaccineThe vaccine made by Pfizer and its partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has ...
- Moderna's COVID-19 vaccine may soon get regulatory approval in IndiaModerna has also informed that the US Government has agreed to donate a certain number of doses of the Moderna COVID-19 vaccine through COV...
- Moderna seeks approval of Covid-19 vaccine for teens in Europe, Canada"We are encouraged that the Moderna Covid-19 vaccine was highly effective at preventing Covid-19 and SARS-CoV-2 infection in adolescents," ...
- Moderna files for full US approval of COVID-19 vaccineThe development comes weeks after rival Pfizer Inc and its German partner BioNTech SE sought full approval for their COVID-19 vaccine in th...
- FDA warns against one-dose regimen for coronavirus vaccinesIn February, some scientists and lawmakers suggested using a one-dose regimen for all coronavirus vaccines approved in the US, after certai...
- Johnson & Johnson’s one-shot vaccine effective, safe: FDA staffJohnson & Johnson’s one-shot Covid-19 vaccine appeared safe and effective in trials, US Food and Drug Administration (FDA) staff said in do...
- US administers first Moderna vaccines to nurse in ConnecticutThe first Moderna inoculations come after the US Food and Drug Administration (FDA) announced late Friday that it had granted emergency app...
- Approval of 2nd COVID-19 vaccine another milestone in US' fight against pandemic: Joe BidenModerna's COVID-19 vaccine mRNA-1273 on Friday became the second drug in the US to get emergency use authorisation from the US FDA, a week ...
- Trump, ahead of FDA, says Moderna's COVID-19 vaccine has been approvedThe FDA had not yet authorized emergency use of the vaccine, a Bloomberg reporter said on Twitter, citing the agency. FDA and Moderna did n...
- COVID-19: Moderna submits vaccine data to obtain emergency use authorisation"Moderna's data for the emergency use authorisation request for mRNA-1273 has been submitted to the US FDA," Moderna tweeted on Monday.
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