FDA

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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Proposed FDA guidelines to strengthen oversight on accelerated approval cancer drugs
Proposed FDA guidelines to strengthen oversight on accelerated approval cancer drugs
Medical Marketing and Media
FDA
clinical trials
cancer
oncology
accelerated approvals
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FDA floats oncology authorization shake-up, pitching 'one-trial' model for accelerated and full approval
FDA floats oncology authorization shake-up, pitching 'one-trial' model for accelerated and full approval
Fierce Biotech
FDA
oncology
regulatory
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BrainStorm Secures FDA Adcomm for ALS Therapy NurOwn
BrainStorm Secures FDA Adcomm for ALS Therapy NurOwn
BioSpace
BrainStorm Cell Therapeutics
NurOwn
ALS
FDA
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FDA approves Pharming drug for ultra-rare immunodeficiency disease
FDA approves Pharming drug for ultra-rare immunodeficiency disease
Endpoints
FDA
Pharming
Novartis
leniolisib
APDS
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FDA outlines plan for digital health technologies for clinical trials
FDA outlines plan for digital health technologies for clinical trials
RAPS.org
FDA
regulatory
clinical trials
digital health
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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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Incyte hit by CRL on extended-release JAK tablets, muddying plans for Jakafi franchise expansion
Incyte hit by CRL on extended-release JAK tablets, muddying plans for Jakafi franchise expansion
Endpoints
Incyte
FDA
ruxolitinib
CRL
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Future of abortion pills hangs in the balance as court hears case against mifepristone
Future of abortion pills hangs in the balance as court hears case against mifepristone
Medical Marketing and Media
abortion pills
FDA
mifepristone
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Secura Bio to keep offering blood cancer drug despite negative ODAC vote, OS questions
Secura Bio to keep offering blood cancer drug despite negative ODAC vote, OS questions
Endpoints
Secura Bio
Copiktra
CLL
small lymphocytic lymphoma
FDA
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FDA approves new antifungal as concerns grow over drug-resistant fungus
FDA approves new antifungal as concerns grow over drug-resistant fungus
BioPharma Dive
FDA
Cidara Therapeutics
Melinta Therapeutics
antifungals
candidemia
candidiasis
Rezzayo
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Ionis Rockets As Biogen-Partnered ALS Drug Wins Key Endorsement
Ionis Rockets As Biogen-Partnered ALS Drug Wins Key Endorsement
Investors Business Daily
Ionis Pharmaceuticals
Biogen
ALS
FDA
tofersen
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In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type
In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type
Fierce Pharma
Incyte
Zynyz
FDA
Merkel cell carcinoma
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FDA advisers support conditional clearance of Biogen’s ALS drug
FDA advisers support conditional clearance of Biogen’s ALS drug
BioPharma Dive
Biogen
ALS
FDA
tofersen
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FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up
FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up
Fierce Pharma
Regeneron
Evkeeza
pediatric
Homozygous Familial Hypercholesterolemia
FDA
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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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Despite CMS snub, Eisai is 'not so nervous' about Leqembi's long-term coverage prospects: US CEO
Despite CMS snub, Eisai is 'not so nervous' about Leqembi's long-term coverage prospects: US CEO
Fierce Pharma
Eisai
Leqembi
FDA
CMS
Alzheimer's disease
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FDA's Peter Marks backs accelerated approval for gene therapies
FDA's Peter Marks backs accelerated approval for gene therapies
BioSpace
FDA
CDER
Peter Marks
gene therapy
accelerated approval
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FDA grants fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 to reduce triglycerides
FDA grants fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 to reduce triglycerides
Pharmaceutical Business Review
Arrowhead Pharmaceuticals
ARO-APOC3
triglycerides
familial chylomicronemia syndrome
fast track
FDA
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FDA’s top cybersecurity officials discuss heightened threats, technology modernization
FDA’s top cybersecurity officials discuss heightened threats, technology modernization
RAPS.org
FDA
cybersecurity
modernization
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