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COVID-19
FDA details plan to end emergency use authorizations for devices
FDA details plan to end emergency use authorizations for devices
Medtech Dive
devices
Medtech
FDA
COVID-19
Emergency Use Authorization
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BioNTech's COVID-19 vaccine revenue forecasts lower than expected
BioNTech's COVID-19 vaccine revenue forecasts lower than expected
Biopharma Reporter
BioNTech
earnings
COVID-19
vaccines
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Brii Bio shelves once-promising COVID antibody combo that stood up to variants
Brii Bio shelves once-promising COVID antibody combo that stood up to variants
Fierce Pharma
Brii Biosciences
COVID-19
BRII-196/198
China
FDA
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Moderna CEO defends price of COVID shot at Senate hearing
Moderna CEO defends price of COVID shot at Senate hearing
BioPharma Dive
Moderna Therapeutics
vaccines
COVID-19
drug pricing
Senate
Bernie Sanders
Stephane Bancel
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FDA to soon decide on second round of Omicron-tailored boosters
FDA to soon decide on second round of Omicron-tailored boosters
Reuters
COVID-19
vaccines
boosters
Omicron
FDA
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The Rise, Fall and Future of Novavax
The Rise, Fall and Future of Novavax
BioSpace
Novavax
vaccines
COVID-19
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FDA adcomm votes in favor of Pfizer's Covid-19 pill Paxlovid
FDA adcomm votes in favor of Pfizer's Covid-19 pill Paxlovid
Endpoints
FDA
Pfizer
Paxlovid
antivirals
COVID-19
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FDA offers radio silence on question of spring Covid boosters, as other countries push ahead
FDA offers radio silence on question of spring Covid boosters, as other countries push ahead
Stat
FDA
boosters
vaccines
COVID-19
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Pfizer (PFE) Gets FDA Nod for Bivalent COVID Shot in Young Children
Pfizer (PFE) Gets FDA Nod for Bivalent COVID Shot in Young Children
Yahoo/Zacks.com
Pfizer
BioNTech
FDA
pediatric
COVID-19
bivalent boosters
vaccines
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Veru Moves Forward with Late-Stage COVID Study Despite FDA Roadblock
Veru Moves Forward with Late-Stage COVID Study Despite FDA Roadblock
BioSpace
Veru
COVID-19
sabizabulin
clinical trials
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FDA staff report says data shows Pfizer’s Covid treatment Paxlovid is effective in high-risk adults
FDA staff report says data shows Pfizer’s Covid treatment Paxlovid is effective in high-risk adults
CNBC
Pfizer
Paxlovid
COVID-19
FDA
antivirals
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Merck asks EMA to reevaluate rejected Covid-19 antiviral
Merck asks EMA to reevaluate rejected Covid-19 antiviral
Endpoints
Merck
Europe
EMA
COVID-19
Lagevrio
molnupiravir
antivirals
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FDA will phase out 22 Covid-19 guidance documents as emergency declaration expires
FDA will phase out 22 Covid-19 guidance documents as emergency declaration expires
Endpoints
COVID-19
regulatory
FDA
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Revamped Covid panel argues for research limits, even bans
Revamped Covid panel argues for research limits, even bans
Stat
R&D
COVID-19
pandemic
federal government
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FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt
FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt
Stat
FDA
diagnostics
COVID-19
Flu
Lucira
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Moderna's COVID vaccine gambit: Hike the price, offer free doses for uninsured
Moderna's COVID vaccine gambit: Hike the price, offer free doses for uninsured
NPR
Moderna Therapeutics
vaccines
COVID-19
drug pricing
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Lucira Gets FDA Authorization for First OTC At-Home Test for COVID-19 and Flu
Lucira Gets FDA Authorization for First OTC At-Home Test for COVID-19 and Flu
Xtalks
Lucira
diagnostics
FDA
COVID-19
Flu
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FDA rejects Covid-19 drug over uncertainties around small trial
FDA rejects Covid-19 drug over uncertainties around small trial
Endpoints
Veru
clinical trials
COVID-19
ARDS
sabizabulin
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US spent nearly $32B in public funds on mRNA vaccine development, study finds
US spent nearly $32B in public funds on mRNA vaccine development, study finds
Endpoints
federal government
funding
COVID-19
vaccines
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Pfizer/BioNTech submit FDA application for Omicron-adapted booster for young children
Pfizer/BioNTech submit FDA application for Omicron-adapted booster for young children
PM Live
Pfizer
BioNTech
FDA
COVID-19
boosters
vaccines
pediatric
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