FDA

FDA scraps AdComm for Reata's rare disease candidate, leaving analysts squinting at the tea leaves
Fierce Biotech
Sun, 10/16/22 - 05:17 pm
Reata Pharmaceuticals
omaveloxolone
FDA
Friedreich's Ataxia
This Week at FDA: Former FDA commissioners push for reforms cut from user fee package
RAPS.org
Sun, 10/16/22 - 05:15 pm
regulatory
FDA
user fees
Scott Gottlieb
Mark McClellan
FDA’s liver safety request set to delay decision on Travere’s kidney drug
Fierce Biotech
Sun, 10/16/22 - 05:12 pm
Travere Therapeutics
kidney disease
REMS
FDA
FDA Review: Phanes, Pfizer, GSK and More
BioSpace
Fri, 10/14/22 - 10:38 am
FDA
Phanes
Pfizer
GSK
Regeneron
Eagle Pharmaceuticals
Galactin Therapeutics
BridgeBio
Gilead Sciences
Covis Pharma
scPharmaceuticals
XACT Robotics
BioMind Labs
‘We have to find a way’: FDA seeks solutions to aid bespoke gene therapy
BioPharma Dive
Fri, 10/14/22 - 10:06 am
FDA
gene therapy
BioMarin gets FDA decision date for hemophilia gene therapy, but questions on review remain
BioPharma Dive
Thu, 10/13/22 - 11:52 pm
Biomarin
FDA
hemophilia A
gene therapy
Roctavian
Study highlights lack of transparency in FDA’s regulatory safety actions
RAPS.org
Thu, 10/13/22 - 09:15 am
FDA
regulatory
transparency
Regeneron secures priority review for Eylea's use in infant retinopathy
Fierce Pharma
Wed, 10/12/22 - 11:40 pm
Eylea
Regeneron
retinopathy of prematurity
FDA
priority review
4 Biotech Stocks With Huge Incoming Catalysts
Motley Fool
Wed, 10/12/22 - 11:03 am
FDA
Biogen
Eisai
Alzheimer's disease
Gilead Sciences
HIV
Mirati Therapeutics
lung cancer
lecanemab
lenacapavir
adagrasib
FDA authorizes Moderna and Pfizer-BioNTech Bivalent COVID vaccines for booster doses in younger age groups
Pharma Live
Wed, 10/12/22 - 10:36 am
FDA
Pfizer
Moderna Therapeutics
BioNTech
vaccines
boosters
bivalent boosters
COVID-19
pediatric
After a rocky few months, Gilead's Trodelvy keeps recent winning streak rolling with priority review
Fierce Pharma
Tue, 10/11/22 - 04:08 pm
Gilead Sciences
breast cancer
Trodelvy
ESMO
FDA
priority review
FDA finalizes guidances on device post-approval studies, postmarket surveillance
RAPS.org
Tue, 10/11/22 - 10:37 am
FDA
regulatory
devices
Medtech
post-approval studies
postmarketing studies
scPharmaceuticals finally wins FDA nod for its on-body infusor for congestive heart failure
Fierce Pharma
Tue, 10/11/22 - 10:30 am
scPharmaceuticals
congestive heart failure
FDA
infusors
Furoscix
devices
Medtech
FDA spurns Supernus for Parkinson's drug, noting application issues 'across several areas'
Endpoints
Mon, 10/10/22 - 06:47 pm
Supernus Pharmaceuticals
FDA
Parkinson's Disease
SPN-830
Omlonti Granted FDA Approval in Glaucoma and Ocular Hypertension
Xtalks
Mon, 10/10/22 - 10:54 am
Omlonti
Santen
UBE Corporation
FDA
ocular hypertension
glaucoma
When Will Novavax Vaccines Be FDA Authorized As Covid-19 Boosters?
Forbes
Mon, 10/10/22 - 10:51 am
Novavax
vaccines
boosters
COVID-19
FDA
FDA Review: Alnylam, Cytokinetics, Eli Lilly and More
BioSpace
Sun, 10/9/22 - 06:06 pm
FDA
Alnylam
Cytokinetics
Eli Lilly
Owlet
Boston Cell Standards
Kiromic Biopharma
Entera Bio
Transcenta Holdings
Kira Pharmaceuticals
Kite Pharma
Poxel
Seneca Therapeutics
CDER proposes withdrawal of approval for Makena
FDA
Sun, 10/9/22 - 05:58 pm
FDA
CDER
Makena
pre-term birth
FDA posts FY2023 user fee tables
RAPS.org
Thu, 10/6/22 - 07:10 pm
FDA
regulatory
user fees
Lilly's tirzepatide slides into FDA fast lane for obesity, turning up heat on Novo Nordisk's Wegovy
Fierce Pharma
Thu, 10/6/22 - 10:59 am
Eli Lilly
Novo Nordisk
obesity
FDA
fast track
tirzepatide

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