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FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic
FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic
BioSpace
COVID-19
pandemic
FDA
drug approvals
biologics
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2020 drug approvals rise despite Covid-19
2020 drug approvals rise despite Covid-19
EP Vantage
drug approvals
FDA
COVID-19
pandemic
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FDA sped progress for most of 2020's novel drugs
FDA sped progress for most of 2020's novel drugs
RAPS.org
FDA
novel drugs
drug approvals
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Even before year-end, 2020's new drug approvals match FDA's 2019 stats
Even before year-end, 2020's new drug approvals match FDA's 2019 stats
RAPS.org
FDA
drug approvals
pandemic
COVID-19
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Drug rejections rise as Covid-19 bites
Drug rejections rise as Covid-19 bites
EP Vantage
COVID-19
drug approvals
Alkermes
ALKS 3831
pandemic
regulatory inspections
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Study: Few new drugs have high therapeutic value
Study: Few new drugs have high therapeutic value
RAPS.org
British Medical Journal
FDA
EMA
therapeutic value
drug approvals
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5 FDA approval decisions to watch in the 4th quarter
5 FDA approval decisions to watch in the 4th quarter
BioPharma Dive
FDA
drug approvals
vaccines
Pfizer
Moderna Therapeutics
COVID-19
Regeneron
EB3
ebola virus
Alkermes
ALKS-3831
schizophrenia
bipolar disorder
Bristol-Myers Squibb
liso-cel
non-Hodgkin lymphoma
roxadustat
FibroGen
chronic kidney disease
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Another strong year for novel drug approvals is in the making
Another strong year for novel drug approvals is in the making
EP Vantage
FDA
drug approvals
regulatory
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COVID-19 Vaccine May Pit Science Against Politics
COVID-19 Vaccine May Pit Science Against Politics
NPR
drug approvals
vaccines
COVID-19
pandemic
politics
Operation Warp Speed
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Top FDA official says would resign if agency rubber-stamps an unproven COVID-19 vaccine
Top FDA official says would resign if agency rubber-stamps an unproven COVID-19 vaccine
Reuters
FDA
vaccines
COVID-19
pandemic
drug approvals
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2 major FDA rejections leave some pharma investors worried about intensification of regulations
2 major FDA rejections leave some pharma investors worried about intensification of regulations
Beckers Hospital Review
FDA
drug approvals
drug development
Gilead Sciences
Biomarin
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Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market
Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market
Drug Patent Watch
generics
FDA
drug approvals
Apixaban
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Go or no go? Valuable drugs set for FDA decisions
Go or no go? Valuable drugs set for FDA decisions
EP Vantage
FDA
drug approvals
Novartis
inclisiran
Biomarin
valrox
Roche
risdiplam
GSK
belantamab mafodotin
Gilead Sciences
Galapagos
filgotinib
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FDA Approvals Roundup: Qwo, Tremfya, Dysport
FDA Approvals Roundup: Qwo, Tremfya, Dysport
RAPS.org
FDA
drug approvals
Endo International
Qwo
cellulite
Ipsen
Dysport
cerebral palsy
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Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals
Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals
RAPS.org
FDA
Stephen Hahn
COVID-19
user fees
drug approvals
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Antimicrobial approvals are not bottlenecked by FDA
Antimicrobial approvals are not bottlenecked by FDA
RAPS.org
FDA
antimicrobials
drug approvals
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FDA Says COVID-19 Could Delay Drug Approvals
FDA Says COVID-19 Could Delay Drug Approvals
Motley Fool
FDA
COVID-19
pandemic
drug approvals
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Alnylam nabs speedy review, setting up 3rd possible approval in 3 years
Alnylam nabs speedy review, setting up 3rd possible approval in 3 years
Endpoints
Alnylam
RNAi
FDA
drug approvals
lumasiran
hyperoxaluria
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From Gilead To AstraZeneca, Investors Should Watch These Biotech Giants Right Now
From Gilead To AstraZeneca, Investors Should Watch These Biotech Giants Right Now
Motley Fool
FDA
drug approvals
Gilead Sciences
remdesivir
AstraZeneca
Merck
Lynparza
Clovis Oncology
Rubraca
Bristol-Myers Squibb
Opdivo
Yervoy
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Study tracks sharp drop in FDA approvals based on 2 pivotal trials
Study tracks sharp drop in FDA approvals based on 2 pivotal trials
RAPS.org
FDA
clinical trials
drug approvals
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