labeling

FDA approves safety labeling changes for opioids
Pharmacist.com
Mon, 12/18/23 - 10:07 pm
FDA
labeling
opioids
FDA Adds New Warning for Ileus to Ozempic Label
HCP Live
Thu, 09/28/23 - 11:55 am
Novo Nordisk
Ozempic
diabetes
weight losss
FDA
ileus
labeling
FDA revises biosimilar guidelines for clearer drug labelling
Pharmaceutical Technology
Mon, 09/18/23 - 07:50 pm
FDA
biosimilars
labeling
Study: Extrapolation used in more than half of pediatric drug labeling changes
RAPS.org
Wed, 02/15/23 - 10:50 am
regulatory
pediatric
extrapolation
labeling
Teva’s generic label not skinny enough to protect from $234M damages to GSK
MedCity News
Sat, 08/7/21 - 11:57 pm
Teva Pharmaceutical
generics
labeling
patents
GSK
Coreg
FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment
BioPharma Dive
Thu, 07/8/21 - 11:17 am
Biogen
Aduhelm
FDA
Alzheimer's disease
labeling
Novartis’ blockbuster heart med Entresto snags FDA approval in larger patient group
Fierce Pharma
Tue, 02/16/21 - 11:40 pm
Novartis
Entresto
heart failure
labeling
FDA
Bristol-Myers, Sanofi ordered to pay Hawaii $834 million over Plavix warning label
Reuters
Tue, 02/16/21 - 11:07 am
Bristol-Myers Squibb
Sanofi
Plavix
Hawaii
deceptive marketing
labeling
GSK, Teva on-again, off-again lawsuit is back on: Will 'skinny labeling' get a reprieve?
Fierce Pharma
Thu, 02/11/21 - 10:47 am
GSK
generics
skinny labels
labeling
Teva Pharmaceutical
FDA goes beyond the label to educate doctors—and enlighten others—about new cancer drugs
Fierce Pharma
Tue, 12/1/20 - 11:30 pm
FDA
physicians
cancer
labeling
What's next for Amarin? CEO John Thero talks Vascepa's label, pricing and future partnerships
Biopharma Dive
Sat, 11/16/19 - 10:35 pm
Amarin
Vascepa
John Thero
labeling
Drugmakers Seek Clarity on Two FDA Labeling Guidances
RAPS.org
Mon, 09/9/19 - 08:12 pm
FDA
labeling
biologics
drug abuse
drug dependence
FDA Drafts Two New Guidances on Drug Labeling
RAPS.org
Mon, 07/1/19 - 07:37 pm
FDA
labeling
drug abuse
IFU
SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case
RAPS.org
Tue, 05/21/19 - 09:28 am
FDA
Merck
labeling
failure-to-warn
Fosamax
FDA finalizes accelerated approval labeling guidance
Endpoints
Wed, 01/23/19 - 09:31 am
FDA
labeling
FDA Withdraws Proposed Rule on Generic Label Changes
RAPS.org
Thu, 12/13/18 - 12:26 pm
FDA
labeling
generics
Stage Set for Merck’s SCOTUS Case Over Warnings in Labels
RAPS.org
Mon, 12/10/18 - 07:08 pm
Merck
warnings
labeling
Supreme Court
3 Things Alnylam's Management Wants Investors to Know About the Launch of Onpattro
Motley Fool
Mon, 08/20/18 - 10:05 am
Alnylam
Onpattro
hATTR amyloidosis
drug pricing
labeling
Indications and Usage: FDA Issues Draft Labeling Guidance
RAPS.org
Fri, 07/6/18 - 10:40 pm
FDA
labeling
FDA approves label update to Novo Nordisk’s Tresiba diabetes drug
Drug Delivery Business News
Mon, 03/26/18 - 10:39 pm
FDA
Novo Nordisk
diabetes
Tresiba
labeling
insulin degludec

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