FDA

No go for Zosano as FDA knockback triggers suspension of transdermal migraine patch program
Fierce Pharma
Tue, 05/3/22 - 10:44 pm
Zosano Pharma
FDA
migraines
migraine patch
M207
FDA clears wearable 3D ultrasound for breast imaging
MedCity News
Tue, 05/3/22 - 10:32 pm
devices
Medtech
FDA
iSono Health
ultrasound
breast imaging
breast cancer
Opiant beats path to FDA after nasal overdose drug matches Narcan
Fierce Pharma
Tue, 05/3/22 - 10:50 am
Opiant Pharmaceuticals
opioids
opioid overdose
Narcan
FDA
FDA grants Prothena fast track designation for Alzheimer’s disease therapy
Biopharma Reporter
Tue, 05/3/22 - 10:46 am
Prothena
FDA
fast track
Alzheimer's status
PRX012
US Bridging Study Not Enough as FDA Denies Hutchmed's Pancreatic Cancer Drug
BioSpace
Mon, 05/2/22 - 06:32 pm
FDA
Hutchmed
pancreatic cancer
surufatinib
As expected, FDA spikes down Axsome migraine med, but issues are 'addressable'
Fierce Biotech
Mon, 05/2/22 - 06:19 pm
Axsome Therapeutics
migraines
FDA
AXS-07
FDA guidance machine churns out 8 new documents in less than a week
Endpoints
Mon, 05/2/22 - 06:17 pm
FDA
regulatory
ulcerative colitis
Crohn's Disease
cancer
clinical trials
A year after CRL, Acadia is going back to bat for Nuplazid at the FDA
Endpoints
Mon, 05/2/22 - 06:15 pm
Acadia Pharmaceuticals
FDA
Nuplazid
Alzheimer's disease psychosis
Sage, Biogen get rolling on FDA submission for depression med
Fierce Biotech
Mon, 05/2/22 - 11:52 am
SAGE Therapeutics
Biogen
zuranolone
FDA
major depressive disorder
It's CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News
BioSpace
Mon, 05/2/22 - 11:44 am
FDA
complete response letter
Junshi Biosciences
Coherus Biosciences
Axsome Therapeutics
migraines
AXS-07
Vertex Falls After FDA Halts Diabetes Study in Surprise Move
Yahoo/Bloomberg
Mon, 05/2/22 - 11:01 am
Vertex Pharmaceuticals
FDA
type 1 diabetes
clinical trials
VX-880
FDA approves expanded indication for Supernus’ Qelbree for ADHD
Pharmaceutical Business Review
Mon, 05/2/22 - 10:59 am
Supernus Pharmaceuticals
Qelbree
ADHD
FDA
AbbVie's red-hot Rinvoq scores fourth FDA approval in five months
Fierce Pharma
Sat, 04/30/22 - 02:34 pm
AbbVie
Rinvoq
FDA
ankylosing spondylitis
FDA tells Praxis it can't move into the clinic just yet for a rare epilepsy drug
Endpoints
Fri, 04/29/22 - 10:45 am
Praxis Precision Medicines
FDA
clinical hold
epilepsy
PRAX-222
Dexcom’s CEO: FDA’s Nod for G7 Could Come Sometime After ADA
Medical Devices and Diagnostics Industry
Fri, 04/29/22 - 10:42 am
DexCom
G7
continuous glucose monitoring
diabetes
FDA
Medtech
devices
FDA lifts hold on Finch’s microbiome crapsule, as company looks to right ship
Endpoints
Fri, 04/29/22 - 10:34 am
Finch Therapeutics
FDA
microbiome
crapsules
clinical trials
C. difficile
FDA to discuss Pfizer, Moderna requests for COVID vaccines in young kids in June
Yahoo/Reuters
Fri, 04/29/22 - 10:19 am
FDA
vaccines
COVID-19
Pfizer
BioNTech
Moderna Therapeutics
Bristol Myers wins FDA approval for first drug to treat inherited heart condition
BioPharma Dive
Thu, 04/28/22 - 10:45 pm
Bristol Myers Squibb
Camzyos
obstructive hypertrophic cardiomyopathy
FDA
Califf wants to create incentives for FDA commissioners to stay longer
RAPS.org
Thu, 04/28/22 - 10:37 pm
FDA
Robert Califf
Moderna seeks FDA clearance for COVID-19 vaccine in young children
BioPharma Dive
Thu, 04/28/22 - 11:09 am
Moderna Therapeutics
pediatric
FDA
vaccines
COVID-19

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