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FDA
Clinical trial diversity is a balancing act of time, quality, and money
Clinical Trials Arena
Fri, 07/26/24 - 11:04 am
clinical trials
clinical trial diversity
FDA
Citius’ first FDA decision date is approaching — and its CEO has millions on the line
Pharma Voice
Fri, 07/26/24 - 10:59 am
Citius Pharmaceuticals
Lymphir
FDA
persistent or recurrent cutaneous T-cell lymphoma
FDA advisers, frustrated by AZ's Imfinzi design, call for revamp of perioperative lung cancer trials
Fierce Pharma
Thu, 07/25/24 - 09:59 pm
FDA
ODAC
clinical trials
non-small cell lung cancer
AstraZeneca
Imfinzi
A public health call to arms: The long build to FDA’s misinformation guidance
Medical Marketing and Media
Thu, 07/25/24 - 09:58 pm
misinformation
regulatory
FDA
FDA Issues Final Guidance for Using Real-World Data in Drug Applications
BioSpace
Thu, 07/25/24 - 11:24 am
FDA
regulatory
real world data
EHRs
FDA medical device chief Shuren to step down after 15 years
BioPharma Dive
Wed, 07/24/24 - 10:59 pm
FDA
Medtech
Jeff Shuren
Neuspera eyes FDA approval for urinary incontinence implant
Clinical Trials Arena
Wed, 07/24/24 - 11:47 am
NeuSpera Medical
Medtech
urinary incontinence
FDA
FDA Flags Potential ‘Overtreatment’ for NSCLC With AstraZeneca’s Imfinzi Ahead of Adcomm
BioSpace
Wed, 07/24/24 - 11:32 am
AstraZeneca
Imfinzi
non-small cell lung cancer
FDA
SEC Hits Allarity With Wells Notice, Flags Alleged Violations in FDA Meeting
BioSpace
Tue, 07/23/24 - 11:32 am
Allarity Therapeutics
SEC
FDA
securities law
Action by FDA ensures trial sponsors must consider diversity
Pharmaphorum
Tue, 07/23/24 - 11:16 am
clinical trials
clinical trial diversity
FDA
BrainStorm Gears Up for Phase IIIb NurOwn Trial Amidst ALS Malaise
BioSpace
Mon, 07/22/24 - 11:29 am
BrainStorm Cell Therapeutics
FDA
ALX
NurOwn
stem cells
FDA launches innovation hub to spur rare disease R&D
Pharmaphorum
Fri, 07/19/24 - 11:37 am
FDA
Rare Diseases
R&D
Phathom Scores Non-Erosive GERD Approval for Heartburn Drug
BioSpace
Thu, 07/18/24 - 11:03 pm
Phathom Pharmaceuticals
FDA
Voquenza
GERD
Orexo’s Opioid Overdose Nasal Spray Fails FDA Review for Second Time
BioSpace
Wed, 07/17/24 - 12:16 pm
Orexo
opioids
opioid overdose
FDA
OX124
FDA proposes cell and gene therapy site tours to help regulators learn from industry
Fierce Pharma
Mon, 07/15/24 - 11:18 pm
cell therapy
gene therapy
FDA
CBER
OTP
Eli Lilly's Alzheimer's Drug Obtains FDA Approval. Here's Why the Stock Isn't Taking Off.
Motley Fool
Mon, 07/15/24 - 09:53 am
Eli Lilly
Kisunla
FDA
Alzheimer's disease`
FDA’s lab-developed test rule could be first test of agency’s power post-Chevron
BioPharma Dive
Sun, 07/14/24 - 10:16 pm
FDA
lab-developed tests
diagnostics
Medtech
Supreme Court
Chevron Doctrine
AbbVie Submits Applications for Rinvoq for Giant Cell Arteritis
Managed Healthcare Executive
Sun, 07/14/24 - 10:12 pm
AbbVie
Rinvoq
FDA
EMA
giant cell arteritis
AskBio receives FDA Fast Track and MHRA Innovation Passport Designations for AB-1005 Investigational GDNF Gene Therapy for Parkinson’s Disease
Drugs.com
Thu, 07/11/24 - 10:55 pm
Bayer
AskBio
FDA
AB-1005
Parkinson's Disease
fast track status
FDA details how pharma companies can counter health misinformation
Medical Marketing and Media
Thu, 07/11/24 - 10:52 pm
FDA
misinformation
social media
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