FDA

5 FDA approval decisions to watch in the 3rd quarter
5 FDA approval decisions to watch in the 3rd quarter
BioPharma Dive
FDA
Gilead Sciences
filgotinib
rheumatoid arthritis
GSK
belantamab mafodotin
Multiple Myeloma
NS Pharma
viltolarsen
Duchenne Muscular Dystrophy
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A flawed Covid-19 study gets the White House’s attention — and the FDA may pay the price
A flawed Covid-19 study gets the White House’s attention — and the FDA may pay the price
Stat
FDA
hydroxychloroquine
COVID-19
White House
clinical trials
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Biogen Alzheimer’s Drug in FDA’s Court Following Completion of Filing
Biogen Alzheimer’s Drug in FDA’s Court Following Completion of Filing
Xconomy
Biogen
FDA
aducanumab
Alzheimer's disease
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Unified agenda: FDA publishes lengthy to-do list
Unified agenda: FDA publishes lengthy to-do list
RAPS.org
FDA
regulatory
devices
de novo pathway
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Concert gets BTD for alopecia drug, setting up a late-stage showdown with giant rival Pfizer
Concert gets BTD for alopecia drug, setting up a late-stage showdown with giant rival Pfizer
Endpoints
Concert Pharmaceuticals
alopecia areata
FDA
CTP-543
breakthrough therapies
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FDA bars the door — for now — against Merck’s star cancer drug after Roche beat them to the punch
FDA bars the door — for now — against Merck’s star cancer drug after Roche beat them to the punch
Endpoints
Merck
FDA
complete response letter
Keytruda
Eisaid
Lenvima
hepatocellular carcinoma
Roche
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FDA Authorizes Becton, Dickinson Portable 15-Minute Coronavirus Test
FDA Authorizes Becton, Dickinson Portable 15-Minute Coronavirus Test
Motley Fool
FDA
Becton Dickinson
diagnostics
Emergency Use Authorization
pandemic
COVID-19
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Death in Cellectis off-the-shelf CAR-T trial triggers FDA hold
Death in Cellectis off-the-shelf CAR-T trial triggers FDA hold
Fierce Biotech
Cellectis
CAR-T
UCARCS1A
Multiple Myeloma
patient deaths
FDA
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GSK snags first-in-class FDA nod for Rukobia to treat HIV patients who have few options
GSK snags first-in-class FDA nod for Rukobia to treat HIV patients who have few options
Fierce Pharma
GSK
ViiV Healthcare
Rukobia
fostemsavir
HIV
FDA
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FDA lifts partial hold on ADC, clearing way for a 2021 readout and two potential near-term approvals
FDA lifts partial hold on ADC, clearing way for a 2021 readout and two potential near-term approvals
Endpoints
ADC Therapeutics
IPOs
FDA
Cami
Hodgkin's lymphoma
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ViiV Healthcare gets FDA nod for HIV drug Rukobia to treat adult patients
ViiV Healthcare gets FDA nod for HIV drug Rukobia to treat adult patients
Pharmaceutical Business Review
ViiV Healthcare
FDA
Rukobia
HIV
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5 FDA-approved antivirals could target COVID-19: study
5 FDA-approved antivirals could target COVID-19: study
Fierce Biotech
FDA
COVID-19
antivirals
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Go or no go? Pandemic looms over FDA timelines
Go or no go? Pandemic looms over FDA timelines
EP Vantage
Jazz Pharma
Gilead Sciences
Galapagos
GSK
FDA
pandemic
COVID-19
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Ultragenyx Pharma Wins FDA’s First Drug Nod for Rare Metabolic Disorder
Ultragenyx Pharma Wins FDA’s First Drug Nod for Rare Metabolic Disorder
Xconomy
Ultragenyx
FDA
long-chain fatty acid oxidation disorders
Dojolvi
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FDA Sets Bar for COVID-19 Vaccine Approval at 50% Effectiveness
FDA Sets Bar for COVID-19 Vaccine Approval at 50% Effectiveness
BioSpace
FDA
vaccines
COVID-19
pandemic
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U.S. FDA to release guidance on COVID-19 vaccine approval
U.S. FDA to release guidance on COVID-19 vaccine approval
Yahoo/Reuters
FDA
vaccines
pandemic
COVID-19
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Merck & Co’s Keytruda gets new colorectal cancer use after month-long FDA review
Merck & Co’s Keytruda gets new colorectal cancer use after month-long FDA review
Pharmaforum
Merck
Keytruda
FDA
colorectal cancer
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Intercept CEO lays into FDA after NASH drug rejection
Intercept CEO lays into FDA after NASH drug rejection
Pharmaforum
Intercept Pharma
Pharma CEOs
NASH
FDA
obeticholic acid
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Roche Gets FDA OK for Injectable Version of Breast Cancer Drug
Roche Gets FDA OK for Injectable Version of Breast Cancer Drug
Xconomy
Roche
HER2+ breast cancer
FDA
Phesgo
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Chiasma secures FDA approval for acromegaly pill Mycapssa years after near-catastrophic rejection
Chiasma secures FDA approval for acromegaly pill Mycapssa years after near-catastrophic rejection
Fierce Pharma
Chiasma
FDA
Mycapssa
acromegaly
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