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FDA
Biden institutes regulatory freeze on first day of presidency
Biden institutes regulatory freeze on first day of presidency
Endpoints
Joe Biden
regulatory
HHS
FDA
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Incyte lands priority review for PD-1 inhibitor in anal cancer
Incyte lands priority review for PD-1 inhibitor in anal cancer
Fierce Biotech
Incyte
FDA
priority review
anal cancer
retifanlimab
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FDA approves first monthly injectable to treat HIV infection
FDA approves first monthly injectable to treat HIV infection
Stat
ViiV
FDA
Cabenuva
HIV
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Pieris finally vaults FDA hold on next-gen solid tumor hunter, clearing the path for mid-stage trial
Pieris finally vaults FDA hold on next-gen solid tumor hunter, clearing the path for mid-stage trial
Endpoints
Pieris
FDA
solid tumors
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With patent concerns looming, Roche gets a new priority review on blockbuster IPF drug
With patent concerns looming, Roche gets a new priority review on blockbuster IPF drug
Endpoints
Roche
Esbriet
IPF
FDA
priority review
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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 veteran Janet Woodcock takes over as acting commissioner in Biden administration
FDA veteran Janet Woodcock takes over as acting commissioner in Biden administration
Fierce Pharma
Janet Woodcock
Joe Biden
FDA
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Glaxo joins the Covid-19 delay queue
Glaxo joins the Covid-19 delay queue
EP Vantage
GSK
dostarlimab
COVID-19
FDA
pandemic
endometrial cancer
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Can Merck and Bayer's newly approved Verquvo stand out in an ever-more-competitive heart failure field?
Can Merck and Bayer's newly approved Verquvo stand out in an ever-more-competitive heart failure field?
Fierce Pharma
Merck
Bayer
FDA
Verquvo
vericiguat
chronic heart failure
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Novo Nordisk files for regulatory approval in the US of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes
Novo Nordisk files for regulatory approval in the US of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes
Yahoo/Global Newswire
Novo Nordisk
FDA
Ozempic
type 2 diabetes
semaglutide
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HHS, FDA dispute spills out onto Twitter
HHS, FDA dispute spills out onto Twitter
RAPS.org
HHS
FDA
Stephen Hahn
twitter
social media
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J&J’s Darzalex Faspro is first US therapy for rare blood disorder
J&J’s Darzalex Faspro is first US therapy for rare blood disorder
Pharmaforum
JNJ
Darzalex Faspro
FDA
light chain amyloidosis
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US eyes permanent change to digital health regulatory path
US eyes permanent change to digital health regulatory path
Pharmaforum
digital health
digital pharma
FDA
pandemic
COVID-19
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Here's the Top FDA Decision to Watch in 2021
Here's the Top FDA Decision to Watch in 2021
Motley Fool
FDA
Biogen
aducanumab
Alzheimer's disease
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Pfizer’s XALKORI approved by FDA for ALK-positive anaplastic large cell lymphoma in children and young adults
Pfizer’s XALKORI approved by FDA for ALK-positive anaplastic large cell lymphoma in children and young adults
Pharmaceutical Business Review
Pfizer
Xalkori
FDA
ALK-positive anaplastic large cell lymphoma
ALCL
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Industry, FDA begin to hammer out PDUFA VII details
Industry, FDA begin to hammer out PDUFA VII details
Endpoints
FDA
PDUFA VII
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Novartis gets FDA breakthrough therapy status for ligelizumab to treat chronic spontaneous urticaria
Novartis gets FDA breakthrough therapy status for ligelizumab to treat chronic spontaneous urticaria
Pharmaceutical Business Review
Novartis
breakthrough therapy
FDA
ligelizumab
chronic spontaneous urticaria
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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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FDA Veteran Being Considered to Lead Agency Under Biden
FDA Veteran Being Considered to Lead Agency Under Biden
Bloomberg
FDA
Janet Woodcock
Joe Biden
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5 questions facing the FDA in 2021
5 questions facing the FDA in 2021
BioPharma Dive
FDA
Joe Biden
COVID-19
pandemic
PDUFA VII
clinical trials
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