FDA

Edwards expects new TAVR approval in mid-2025 to boost sales
Medtech Dive
Thu, 12/5/24 - 04:10 pm
Medtech
Edwards Lifesciences
TAVR
FDA
asymptomatic severe aortic stenosis
FDA clears AZ's Imfinzi for aggressive lung cancer
Pharmaphorum
Thu, 12/5/24 - 11:10 am
AstraZeneca
Imfinzi
small cell lung cancer
FDA
With Makary set to face FDA commissioner hearings, how deep do his industry ties run?
Pharma Voice
Wed, 12/4/24 - 10:35 am
FDA
Marty Makary
Donald Trump
FDA kicks off review of Cytokinetics' aficamten for HCM
Pharmaphorum
Tue, 12/3/24 - 09:39 am
Cytokinetics
FDA
aficamten
obstructive hypertrophic cardiomyopathy
Bristol Myers Squibb
Camzyos
FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports
Fierce Pharma
Mon, 12/2/24 - 07:46 pm
Bluebird Bio
Skysona
gene therapy
FDA
blood cancer
cALD
Former FDA chief Gottlieb weighs in on RFK Jr. pick for HHS
Fierce Pharma
Mon, 12/2/24 - 07:20 pm
Scott Gottlieb
FDA
Robert F Kennedy Jr.
HHS
FDA rejects Applied filing for rare disease approval on clinical grounds, sinking stock
Fierce Biotech
Mon, 12/2/24 - 11:06 am
Applied Therapeutics
FDA
govorestat
galactosemia
FDA oncology advisory committee to weigh Exelixis' Cabometyx in neuroendocrine tumors
Fierce Pharma
Sun, 12/1/24 - 11:52 am
Exelixis
Cabometyx
neuroendocrine tumors
FDA
FDA probes blood cancer risk from bluebird's gene therapy, weighs regulatory action
Medpage Today
Wed, 11/27/24 - 09:59 pm
Bluebird Bio
Skysona
FDA
myelodysplastic syndrome
AML
cALD
Alnylam cashes in priority review voucher to catch up to BridgeBio in ATTR-CM race
First Word Pharma
Tue, 11/26/24 - 11:04 am
Alnylam
FDA
RNAi
vutrisiran
ATTR-CM
Biohaven fails phase 3 SMA test but plans talks with FDA, plots move into obesity
Fierce Biotech
Mon, 11/25/24 - 11:22 am
Biohaven
taldefgrobep alfa
SMA
spinal muscular atrophy
FDA
obesity
Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
BioPharma Dive
Sun, 11/24/24 - 06:03 pm
Marty Makary
FDA
Donald Trump
BridgeBio heart drug approved by FDA, setting up battle with Pfizer
BioPharma Dive
Sun, 11/24/24 - 05:58 pm
BridgeBio
FDA
Attruby
acoramidis
transthyretin amyloidosis cardiomyopathy
Pfizer
tafamidis
Lexicon to disband sales team, lay off 60% of staff
BioPharma Dive
Fri, 11/22/24 - 11:22 am
Lexicon Pharmaceuticals
FDA
Zynquista
layoffs
Florida drug importation plan stalls nearly a year after approval
Beckers Hospital Review
Fri, 11/22/24 - 11:13 am
drug importation
Florida
FDA
Canada
FDA finds widely used asthma drug impacts the brain, Reuters reports
CNBC
Fri, 11/22/24 - 11:11 am
Merck
FDA
asthma
Singulair
FDA experts lukewarm on AZ's anticoagulant antidote Andexxa
Pharmaphorum
Fri, 11/22/24 - 11:07 am
AstraZeneca
AndexXa
anticoagulant reversal
FDA
COVID-19 critic Marty Makary is Trump’s likely pick for FDA top post
BioSpace
Thu, 11/21/24 - 11:56 am
FDA
regulatory
Marty Makary
Donald Trump
Bayer expands indications for Nubeqa with new drug application
Clinical Trials Arena
Thu, 11/21/24 - 11:39 am
Bayer
Nubeqa
prostate cancer
FDA
Jazz's HER2 bispecific snags FDA nod, teeing up showdown with AZ and Daiichi's Enhertu
Fierce Pharma
Thu, 11/21/24 - 11:18 am
Jazz Pharma
FDA
HER2 Inhibitor
bispecifics
zanidatamab

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