FDA

Novo Nordisk pulls its FDA heart failure submission for Wegovy, will reapply early next year
Fierce Pharma
Wed, 08/7/24 - 11:47 am
Novo Nordisk
heart failure
obesity
Wegovy
FDA
FDA grants IND clearance for Indapta’s multiple sclerosis treatment trial
Clinical Trials Arena
Wed, 08/7/24 - 11:40 am
Indapta
FDA
multiple sclerosis
MS
clinical trials
IDP-023
Servier snags FDA approval for Voranigo, the 1st targeted therapy for a common type of brain tumor
Fierce Pharma
Tue, 08/6/24 - 05:57 pm
Servier
FDA
Voranigo
brain cancer
glioma
Inspire wins FDA approval for obstructive sleep apnea neurostimulator therapy
Medtech Dive
Mon, 08/5/24 - 11:10 pm
Medtech
Inspire Medical Systems
FDA
obstructive sleep apnea
neurostimulation
Experts fear patient harm from FDA’s lab developed test rule
Medtech Dive
Mon, 08/5/24 - 11:08 pm
Medtech
diagnostics
FDA
regulatory
patients
Lykos’ MDMA-Assisted PTSD Therapy Heads to FDA After Adcomm Setback
BioSpace
Mon, 08/5/24 - 11:06 am
Lykos Therapeutics
MDMA
PTSD
FDA
FDA sinks Actinium's radiotherapy blood cancer filing plans, prompting pivot to partnering
Fierce Biotech
Mon, 08/5/24 - 11:01 am
Actinium Pharmaceuticals
FDA
clinical trials
radiotherapy
Iomab-B
FDA says all doses of Lilly's weight-loss and diabetes drug are now available
Reuters
Sun, 08/4/24 - 06:44 pm
Eli Lilly
FDA
Zepbound
Mounjaro
drug shortages
Zevra: FDA Advisory Committee Votes Favorably on Arimoclomol for NPC Patients
Marketwatch
Sun, 08/4/24 - 06:32 pm
Zevra Therapeutics
FDA
arimoclomol
Niemann-Pick disease
J&J's DePuy Synthes nets clearance for Velys spine surgery robot
Fierce Biotech
Fri, 08/2/24 - 11:56 am
JNJ
Medtech
FDA
robotic surgery
spine surgery
Velys Spine system
DePuy Synthes
FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor
Fierce Pharma
Fri, 08/2/24 - 11:32 am
Adaptimmune
FDA
Tecelra
afami-cel
synovial sarcoma
GSK blows Jemperli marching brass against Keytruda with expanded FDA nod in endometrial cancer
Fierce Pharma
Thu, 08/1/24 - 11:19 pm
GSK
Jemperli
Merck
Keytruda
FDA
endometrial cancer
FDA drug application costs set to rise to $4.3m from October
Clinical Trials Arena
Wed, 07/31/24 - 10:38 am
FDA
regulatory
fees
Vertex gets January 30 decision date for non-opioid pain med suzetrigine
Businesswire
Tue, 07/30/24 - 06:40 pm
Vertex Pharmaceuticals
suzetrigine
non-opioid pain treatments
FDA
FDA’s Diversity Action Plan may set a new paradigm for trial transparency
Cl
Tue, 07/30/24 - 11:46 am
FDA
regulatory
clinical trials
clinical trial diversity
FDA approves Alpha Cognition's Zunveyl for mild-to-moderate Alzheimer disease
Neurology Live
Mon, 07/29/24 - 10:58 am
Alpha Cognition
FDA
Zunveyl
ALPHA-1062
Alzheimer's disease
FDA places vTv's lead diabetes drug on hold over chromatographic signal
Fierce Biotech
Mon, 07/29/24 - 10:49 am
vTv Therapeutics
clinical trials
FDA
cadisegliatin
chromatogaphic sigma;
FDA approves Guardant Health's blood-based cancer test
Reuters
Mon, 07/29/24 - 10:41 am
FDA
diagnostics
Guardant Health
colorectal cancer
Shield
Medtech
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

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