FDA

Zepbound, Mounjaro shortages are resolved, FDA confirms
BioPharma Dive
Thu, 12/19/24 - 09:36 pm
FDA
Eli Lilly
Zepbound
Mounjaro
drug shortages
FDA rejects Zealand Pharma's GLP-2 analog in rare bowel disease
Fierce Biotech
Thu, 12/19/24 - 09:29 pm
Zealand Pharma
glepaglutide
FDA
short bowel syndrome
Ionis Pharma's TRYNGOLZA Receives FDA Approval For Genetic Disorder Treatment
NASDAQ
Thu, 12/19/24 - 09:26 pm
Ionis Pharmaceuticals
FDA
Tryngolza
hypertriglyceridemia
Xcovery wins FDA approval for ALK inhibitor in NSCLC
First Word Pharma
Thu, 12/19/24 - 09:18 pm
Xcovery
FDA
Ensacove
ALK inhibitors
non-small cell lung cancer
FDA approves Mesoblast's cell therapy for graft-versus-host disease
Investing.com
Wed, 12/18/24 - 07:52 pm
FDA
Mesoblast
cell therapy
graft vs host disease
Ryoncil
FDA adds liver injury warning for Veozah
Beckers Hospital Review
Wed, 12/18/24 - 11:26 am
FDA
black box
Astellas
Veozah
liver injury
hot flashes
menopause
FDA grants fast-track status to combination mRNA flu and COVID-19 vaccine candidates
Beckers Hospital Review
Tue, 12/17/24 - 12:09 pm
Sanofi
Novavax
COVID-19
vaccines
FDA
fast track
MRNA
Flu
FDA dents J&J's blockbuster hopes for Rybrevant
Pharmaphorum
Tue, 12/17/24 - 11:53 am
JNJ
Rybrevant
FDA
FDA Grants Breakthrough Therapy Designation to Sanofi’s Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis
Pharm Exec
Mon, 12/16/24 - 11:35 am
Sanofi
tolebrutinib
MS
non-relapsing secondary progressive MS
FDA
Galderma adds new indication for blockbuster hope Nemluvio News
Pharmaphorum
Mon, 12/16/24 - 11:19 am
Galderma
FDA
Nemluvio
atopic dermatitis
Neurocrine Wins FDA Approval For Genetic Disorder Drug
MSN/Investors Business Daily
Sun, 12/15/24 - 10:43 pm
Neurocrine Biosciences
FDA
Crenessity
CAH
4 takeaways from the FDA’s first digital health advisory committee
Medtech Dive
Fri, 12/13/24 - 11:33 am
Medtech
digital health
FDA
regulatory
health equity
artificial intelligence
UniQure Stock Doubles After Striking A Deal With The FDA For Huntington's Drug
Investors Business Daily
Tue, 12/10/24 - 11:31 am
uniQure
FDA
Huntington's disease
AMT-130
AbbVie's Parkinson's prospect hits again in phase 3, completing clean sweep to tee up FDA filing
Fierce Biotech
Mon, 12/9/24 - 11:09 am
AbbVie
Parkinson's Disease
tavapadon
FDA
FDA outlines accelerated review guidelines in waning days of Biden administration
BioSpace
Fri, 12/6/24 - 11:23 am
FDA
regulatory
accelerated reviews
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

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