FDA

Quidel Rapid Antigen Test for COVID-19 Wins Authorization
Quidel Rapid Antigen Test for COVID-19 Wins Authorization
Motley Fool
Quidel
Emergency Use Authorization
FDA
diagnostics
antigen tests
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UniQure/CSL hit by FDA clinical hold for hem B gene therapy program after liver cancer find
UniQure/CSL hit by FDA clinical hold for hem B gene therapy program after liver cancer find
Fierce Biotech
uniQure
CSL
FDA
clinical trials
hemophilia B
gene therapy
etranacogene dezaparvovec
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3 Biotech Stocks That Could Explode Higher in 2021
3 Biotech Stocks That Could Explode Higher in 2021
Motley Fool
biotech
biotech stocks
clinical trials
FDA
Argenx
Axsome Therapeutics
CRISPR Therapeutics
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FDA Refuses to Approve Novartis' $9.7 Billion Cholesterol Drug for Now
FDA Refuses to Approve Novartis' $9.7 Billion Cholesterol Drug for Now
Motley Fool
Novartis
FDA
cholesterol
inclisiran
complete response letter
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In groundbreaking move, FDA approves Myovant's relugolix as the first once-a-day pill for advanced prostate cancer
In groundbreaking move, FDA approves Myovant's relugolix as the first once-a-day pill for advanced prostate cancer
Endpoints
Myovant Sciences
Relugolix
FDA
prostate cancer
Orgovyx
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First-quarter catalysts for the smaller players
First-quarter catalysts for the smaller players
EP Vantage
FDA
Supernus
Wave Life Sciences
Rhythm
Calithera
Matinas
Regenexbio
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FDA grants priority review to KEYTRUDA for treatment of esophageal and gastroesophageal junction cancer
FDA grants priority review to KEYTRUDA for treatment of esophageal and gastroesophageal junction cancer
Pharmaceutical Business Review
Merck
Keytruda
FDA
esophageal cancer
gastroesophageal cancer
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In historic vote, mRNA vaccines go 2 and 0 as FDA experts unanimously back Moderna's Covid-19 vaccine
In historic vote, mRNA vaccines go 2 and 0 as FDA experts unanimously back Moderna's Covid-19 vaccine
Endpoints
FDA
MRNA
Moderna Therapeutics
COVID-19
vaccines
Pfizer
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Lilly and Regeneron COVID-19 antibodies are available all over the U.S. Why aren't they getting to more patients?
Lilly and Regeneron COVID-19 antibodies are available all over the U.S. Why aren't they getting to more patients?
Fierce Pharma
FDA
Eli Lilly
Regeneron
antibodies
COVID-19
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MacroGenics wins FDA approval of breast cancer drug
MacroGenics wins FDA approval of breast cancer drug
BioPharma Dive
Margenza
Macrogenics
FDA
breast cancer
Roche
Herceptin
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Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote
Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote
BioSpace
Moderna Therapeutics
COVID-19
vaccines
FDA
advisory panel
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FDA authorizes Abbott’s rapid $25 Covid test for at-home use
FDA authorizes Abbott’s rapid $25 Covid test for at-home use
CNBC
Abbott Labs
diagnostics
COVID-19
FDA
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The More You Know: FDA Provides Additional Guidance on Biosimilars
The More You Know: FDA Provides Additional Guidance on Biosimilars
FDA Law Blog
FDA
biosimilars
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[video+transcript]What Pfizer's Vaccine Authorization Means for Moderna
[video+transcript]What Pfizer's Vaccine Authorization Means for Moderna
Motley Fool
FDA
Emergency Use Authorization
vaccines
COVID-19
Pfizer
Moderna Therapeutics
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First OTC, at-home COVID-19 test garners EUA
First OTC, at-home COVID-19 test garners EUA
RAPS.org
COVID-19
diagnostics
FDA
OTC
Ellume
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Mesoblast spins a PhIII cell therapy miss in heart failure as a win, highlighting positive mortality data
Mesoblast spins a PhIII cell therapy miss in heart failure as a win, highlighting positive mortality data
Endpoints
Mesoblast
FDA
clinical trials
rexlemestrocel-L
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FDA scientists endorse Moderna Covid-19 vaccine, as documents provide new hints on efficacy
FDA scientists endorse Moderna Covid-19 vaccine, as documents provide new hints on efficacy
Stat
FDA
Moderna Therapeutics
vaccines
COVID-19
mRNA 1273
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Regeneron's blood cancer hopeful odronextamab hit with FDA partial hold across several trials
Regeneron's blood cancer hopeful odronextamab hit with FDA partial hold across several trials
Fierce Biotech
Regeneron
FDA
clinical trials
odronextamab
B-cell non-Hodgkin lymphoma
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[video+transcript]Why the U.K. Beat the U.S. in Authorizing a COVID Vaccine
[video+transcript]Why the U.K. Beat the U.S. in Authorizing a COVID Vaccine
Motley Fool
UK
FDA
COVID-19
vaccines
Pfizer
BioNTech
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FDA grants historic authorization to a Covid-19 vaccine, setting stage for rollout
FDA grants historic authorization to a Covid-19 vaccine, setting stage for rollout
Stat
Pfizer
BioNTech
vaccines
FDA
COVID-19
Emergency Use Authorization
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