FDA

CRISPR Therapeutics, Vertex Get FDA Green Light for Sickle Cell Test
CRISPR Therapeutics, Vertex Get FDA Green Light for Sickle Cell Test
Xconomy
CRISPR Therapeutics
Vertex Pharmaceuticals
sickle cell disease
FDA
CTX001
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Senators Urge FDA to Clarify Intentions for Digital Health Pre-Cert Program
Senators Urge FDA to Clarify Intentions for Digital Health Pre-Cert Program
RAPS.org
FDA
pre-certification
digital health
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Celgene notches positive Otezla data in scalp psoriasis as it guns for market expansion
Celgene notches positive Otezla data in scalp psoriasis as it guns for market expansion
Fierce Pharma
Celgene
Otezla
scalp psoriasis
FDA
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Trevena shares sink on FDA concerns ahead of key panel meeting
Trevena shares sink on FDA concerns ahead of key panel meeting
Biopharma Dive
Trevena
FDA
advisory panels
oliceridine
opioids
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FDA reviewers endorse Celltrion's Rituxan biosimilar ahead of panel vote
FDA reviewers endorse Celltrion's Rituxan biosimilar ahead of panel vote
Fierce Pharma
Celltrion
Roche
biosimilars
Rituxan
FDA
advisory panels
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FDA Releases New Draft Guidance to Aid Development of Generic Versions of Complex Drugs
FDA Releases New Draft Guidance to Aid Development of Generic Versions of Complex Drugs
CP Wire
FDA
generics
Scott Gottlieb
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FDA Releases New Draft Guidance to Aid Development of Generic Versions of Complex Drugs
FDA
Scott Gottlieb
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Study Shows Drugs on FDA Shortage List Are Likely to See Price Hikes
Study Shows Drugs on FDA Shortage List Are Likely to See Price Hikes
BioSpace
FDA
drug shortages
drug pricing
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Reorganization of OND to support new drug review modernization, Woodcock says
Reorganization of OND to support new drug review modernization, Woodcock says
Endpoints
FDA
OND
Janet Woodcock
drug reviews
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VistaGen’s AV-101 Snags Fast Track Designation, Other Drugmakers Move Ahead with Non-Opioid Pain Treatment Programs
VistaGen’s AV-101 Snags Fast Track Designation, Other Drugmakers Move Ahead with Non-Opioid Pain Treatment Programs
BioSpace
VistaGen
AV-101
FDA
fast track
neuropathic pain
BioWave
Virpax Pharmaceuticals
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FDA grants de novo nod for Bose self-fitted hearing aid
FDA grants de novo nod for Bose self-fitted hearing aid
Mass Device
FDA
DeNovo
Bose
hearing aid
devices
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FDA expands use of an HPV vaccine up to age 45
FDA expands use of an HPV vaccine up to age 45
Stat
FDA
Gardasil 9
Merck
HPV
vaccines
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How Fast are the FDA Fast Lanes?
How Fast are the FDA Fast Lanes?
PharmExec
FDA
fast track
drug approvals
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Should FDA Treat Rare Disease Drugs Differently?
Should FDA Treat Rare Disease Drugs Differently?
MedPage
FDA
patients
Rare Diseases
orphan diseases
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FDA clears rare disease therapy from Akcea, Ionis
FDA clears rare disease therapy from Akcea, Ionis
Biopharma Dive
FDA
Akcea
Ionis Pharmaceuticals
Tegsedi
Onpattro
Alnylam
hATTR amyloidosis
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FDA Congratulates Itself on Apple’s New Medical Apps
FDA Congratulates Itself on Apple’s New Medical Apps
Medical Devices and Diagnostics Industry
FDA
devices
mobile apps
Apple
DeNovo
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Salix arms its GI salesforce with 2nd liver treatment in Doptelet co-promotional deal
Salix arms its GI salesforce with 2nd liver treatment in Doptelet co-promotional deal
Fierce Pharma
Salix
Dova Pharmaceuticals
Doptelet
FDA
chronic liver disease
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A double date with destiny for Alkermes
A double date with destiny for Alkermes
EP Vantage
Alkermes
FDA
clinical trials
ALKS 5461
ALKS 3831
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FDA Approves Roche Drug For All Hemophilia A Patients, But Rivals Loom
FDA Approves Roche Drug For All Hemophilia A Patients, But Rivals Loom
Xconomy
hemophilia A
FDA
Roche
Hemlibra
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FDA could set record low for drug marketing warning letters — again
FDA could set record low for drug marketing warning letters — again
Biopharma Dive
FDA
warnings
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