FDA

Surmodics Takes a Second Swing at FDA Approval
Medical Devices and Diagnostics Industry
Wed, 06/14/23 - 10:20 am
SurModics
Medtech
SurVeil
drug-coated balloons
FDA
Merck Gets FDA Fast Track for Efinopegdutide, Previews NASH Data Versus Novo’s Semaglutide
BioSpace
Wed, 06/14/23 - 10:08 am
Merck
efinopegdutide
FDA
NASH
fast track
Ferring, with manufacturing update, takes a step towards first gene therapy sales
BioPharma Dive
Wed, 06/14/23 - 10:07 am
Ferring Pharmaceuticals
FDA
bladder cancer
gene therapy
Adstiladrin
FDA approves 1st pediatric drug for functional constipation
Beckers Hospital Review
Tue, 06/13/23 - 10:58 pm
Ironwood Pharmaceuticals
FDA
Linzess
pediatric
constipation
COVID shots should target XBB variants in 2023-24 campaign, US FDA staff say
Yahoo/Reuters
Mon, 06/12/23 - 11:28 pm
FDA
COVID-19
vaccines
XBB variants
FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug
BioPharma Dive
Sun, 06/11/23 - 11:14 pm
Eisai
Biogen
Leqembi
FDA
Alzheimer's disease
FDA’s letter to medical device maker iRhythm is a warning for the industry
Stat
Sun, 06/11/23 - 11:04 pm
iRhythm Technologies
Medtech
FDA
Zio AT heart monitor
Landmark approval for Vertex's CRISPR drug 2 steps closer after trial wins, PDUFA date granted
Fierce Biotech
Fri, 06/9/23 - 10:07 am
Vertex Pharmaceuticals
CRISPR Therapeutics
CRISPR
gene editing
FDA
sickle cell disease
beta thalassemia
FDA advisers recommend approval of monoclonal antibody to protect newborns and young children from RSV
Stat
Thu, 06/8/23 - 09:47 pm
AstraZeneca
RSV
FDA
monoclonal antibodies
pediatric
Beyfortus
FDA: iRhythm targeted heart monitor at ‘high-risk’ patients without seeking clearance
Medtech Dive
Thu, 06/8/23 - 09:58 am
iRhythm Technologies
FDA
Medtech
Zio AT heart monitor
Ahead of key meeting, FDA appears open to full approval of Alzheimer’s drug Leqembi
BioPharma Dive
Wed, 06/7/23 - 09:53 pm
FDA
Eisai
Biogen
Leqembi
Alzheimer's disease
FDA sets the stage for adcomm on Sanofi, AZ's RSV prospect later this week
Fierce Pharma
Wed, 06/7/23 - 09:42 pm
Sanofi
AstraZeneca
GSK
Pfizer
RSV
vaccines
FDA
Alzheimer’s Drug Market To Hit $13 Billion As FDA Approvals And Insurance Coverage Escalate
Forbes
Wed, 06/7/23 - 09:34 pm
Alzheimer's disease
FDA
insurance
Leqembia
Biogen
Eisai
Eli Lilly
donanemab
FDA approves Merck's letermovir to prevent CMV in kidney transplant recipients
Healio
Tue, 06/6/23 - 04:16 pm
Merck
FDA
letermovir
CMV
kidney transplants
Prevymis
FDA sets advisory meeting date for Brainstorm’s ALS cell therapy
BioPharma Dive
Tue, 06/6/23 - 04:11 pm
BrainStorm Cell Therapeutics
FDA
NurOwn
cell therapy
ALS
FDA Removes Expert with Ties to Eisai, Biogen from Leqembi Adcomm
BioSpace
Tue, 06/6/23 - 10:17 am
FDA
Biogen
Eisai
Alzheimer's disease
Leqembi
Foghorn finally has clear route back to clinic after FDA lifts yearlong hold on blood cancer drug
Fierce Biotech
Tue, 06/6/23 - 10:01 am
Foghorn Therapeutics
FHD-286
FDA
blood cancer
FDA’s workforce goals: tackling recruitment, retention and burnout
Medical Marketing and Media
Mon, 06/5/23 - 09:52 pm
FDA
regulatory
FDA rejects Clovis' long-shot bid for approval of Rubraca
Fierce Pharma
Mon, 06/5/23 - 11:29 am
Clovis Oncology
Rubraca
FDA
bankruptcy
After FDA's delayed hold for multiple myeloma drug, Molecular Templates is back in action
Fierce Biotech
Thu, 06/1/23 - 06:38 pm
Molecular Templates
clinical trials
MT-0169
FDA
Multiple Myeloma

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