labeling

FDA revises biosimilar guidelines for clearer drug labelling
FDA revises biosimilar guidelines for clearer drug labelling
Pharmaceutical Technology
FDA
biosimilars
labeling
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Study: Extrapolation used in more than half of pediatric drug labeling changes
Study: Extrapolation used in more than half of pediatric drug labeling changes
RAPS.org
regulatory
pediatric
extrapolation
labeling
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Teva’s generic label not skinny enough to protect from $234M damages to GSK
Teva’s generic label not skinny enough to protect from $234M damages to GSK
MedCity News
Teva Pharmaceutical
generics
labeling
patents
GSK
Coreg
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FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment
FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment
BioPharma Dive
Biogen
Aduhelm
FDA
Alzheimer's disease
labeling
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Novartis’ blockbuster heart med Entresto snags FDA approval in larger patient group
Novartis’ blockbuster heart med Entresto snags FDA approval in larger patient group
Fierce Pharma
Novartis
Entresto
heart failure
labeling
FDA
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Bristol-Myers, Sanofi ordered to pay Hawaii $834 million over Plavix warning label
Bristol-Myers, Sanofi ordered to pay Hawaii $834 million over Plavix warning label
Reuters
Bristol-Myers Squibb
Sanofi
Plavix
Hawaii
deceptive marketing
labeling
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GSK, Teva on-again, off-again lawsuit is back on: Will 'skinny labeling' get a reprieve?
GSK, Teva on-again, off-again lawsuit is back on: Will 'skinny labeling' get a reprieve?
Fierce Pharma
GSK
generics
skinny labels
labeling
Teva Pharmaceutical
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FDA goes beyond the label to educate doctors—and enlighten others—about new cancer drugs
FDA goes beyond the label to educate doctors—and enlighten others—about new cancer drugs
Fierce Pharma
FDA
physicians
cancer
labeling
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What's next for Amarin? CEO John Thero talks Vascepa's label, pricing and future partnerships
What's next for Amarin? CEO John Thero talks Vascepa's label, pricing and future partnerships
Biopharma Dive
Amarin
Vascepa
John Thero
labeling
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Drugmakers Seek Clarity on Two FDA Labeling Guidances
Drugmakers Seek Clarity on Two FDA Labeling Guidances
RAPS.org
FDA
labeling
biologics
drug abuse
drug dependence
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FDA Drafts Two New Guidances on Drug Labeling
FDA Drafts Two New Guidances on Drug Labeling
RAPS.org
FDA
labeling
drug abuse
IFU
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SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case
SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case
RAPS.org
FDA
Merck
labeling
failure-to-warn
Fosamax
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FDA finalizes accelerated approval labeling guidance
FDA finalizes accelerated approval labeling guidance
Endpoints
FDA
labeling
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FDA Withdraws Proposed Rule on Generic Label Changes
FDA Withdraws Proposed Rule on Generic Label Changes
RAPS.org
FDA
labeling
generics
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Stage Set for Merck’s SCOTUS Case Over Warnings in Labels
Stage Set for Merck’s SCOTUS Case Over Warnings in Labels
RAPS.org
Merck
warnings
labeling
Supreme Court
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3 Things Alnylam's Management Wants Investors to Know About the Launch of Onpattro
3 Things Alnylam's Management Wants Investors to Know About the Launch of Onpattro
Motley Fool
Alnylam
Onpattro
hATTR amyloidosis
drug pricing
labeling
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Indications and Usage: FDA Issues Draft Labeling Guidance
Indications and Usage: FDA Issues Draft Labeling Guidance
RAPS.org
FDA
labeling
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FDA approves label update to Novo Nordisk’s Tresiba diabetes drug
FDA approves label update to Novo Nordisk’s Tresiba diabetes drug
Drug Delivery Business News
FDA
Novo Nordisk
diabetes
Tresiba
labeling
insulin degludec
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GSK Announces Positive EU Approval for Labelling Update to Relvar Ellipta in Patients with Asthma
GSK Announces Positive EU Approval for Labelling Update to Relvar Ellipta in Patients with Asthma
Businesswire
GSK
Europe
labeling
Relvar Ellipta
asthma
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FDA revises label on opioid cold meds to limit pediatric use
FDA revises label on opioid cold meds to limit pediatric use
Drug Delivery Business News
FDA
opioids
pediatrics
labeling
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