FDA

'Like salmon swimming upstream': FDA's Peter Marks lays out plan to boost gene therapy approvals
Fierce Biotech
Wed, 04/5/23 - 07:13 pm
FDA
gene therapy
Peter Marks
Uptick in FDA adcomms coming in 2023 as CDER hiring picks up, Cavazzoni says
Endpoints
Wed, 04/5/23 - 07:12 pm
FDA
CDER
advisory committees
FDA Grants EUA to InflaRx’s Anti-Inflammatory COVID-19 Treatment
BioSpace
Wed, 04/5/23 - 10:21 am
Inflarx
vilobelimab
Gohibic
COVID-19
FDA
FDA Accepts SNDAs For Pfizer's Braftovi + Mektovi
NASDAQ
Wed, 04/5/23 - 10:18 am
Pfizer
FDA
Braftovi
Mektovi
metastatic non-small cell lung cancer
Promising candidate for NASH submitted to FDA as IND
Clinical Trials Arena
Tue, 04/4/23 - 11:14 pm
NeuroBo
FDA
clinical trials
NASH
FDA Approves Keytruda/Padcev Combo in Advanced Urothelial Cancer
BioSpace
Tue, 04/4/23 - 12:35 pm
Merck
Seagen
Astellas
Keytruda
Padcev
metastatic urothelial carcinoma
FDA
FDA cites ‘deficiencies’ in Ascendis’ application for parathyroid drug, jeopardizing potential approval
Endpoints
Tue, 04/4/23 - 12:32 pm
Ascendis Pharma
hypoparathyroidism
FDA
FDA grants orphan drug designation to HuidaGene gene therapy for blindness
Pharmaceutical Business Review
Tue, 04/4/23 - 12:25 pm
HuidaGene
HG004
gene therapy
FDA
retinal disease
5 FDA decisions to watch in the second quarter
BioPharma Dive
Mon, 04/3/23 - 11:06 pm
FDA
Sarepta Therapeutics
Duchenne Muscular Dystrophy
Biogen
tofersen
ALS
Seres Therapeutics
C. difficile
Pfizer
GSK
vaccines
RSV
Regeneron
Eylea
Vertex and CRISPR Therapeutics Complete Submission of Rolling Biologics License Applications (BLAs) to the US FDA for exa-cel for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
Yahoo/Businesswire
Mon, 04/3/23 - 10:09 am
Vertex Pharmaceuticals
CRISPR Therapeutics
sickle cell disease
beta thalassemia
FDA
exa-cel
Go or no go? Seagen's Padcev eyes FDA approval
EP Vantage
Mon, 04/3/23 - 09:41 am
FDA
AbbVie
Alvotech
Ascendis Pharma
Astellas
AstraZeneca
Biogen
Daiichi Sankyo
Eli Lilly
Ferring Pharmaceuticals
Hugel
Innoviva
Ionis Pharmaceuticals
Lundbeck
Merck
Novo Nordisk
Otsuka
Pfizer
Roche Seagen
Seres Therapeutics
Takeda
UCB
Vertex Pharmaceuticals
Abbott Continues Its Sterling 2023 with Epic Max FDA Clearance
Medical Devices and Diagnostics Industry
Sun, 04/2/23 - 04:22 pm
Abbott Labs
Medtech
FDA
Epic Max
aortic stenosis
New lupus partnership with FDA aims to end drug trials’ history of failure
Stat
Thu, 03/30/23 - 11:08 pm
lupus
FDA
clinical trials
US lawmakers again propose diagnostics reform bill
RAPS.org
Thu, 03/30/23 - 11:00 pm
legislation
FDA
diagnostics
CMS
Court Sides with Vanda Against FDA in Freedom of Information Act Case
BioSpace
Thu, 03/30/23 - 10:08 am
Vanda Pharmaceuticals
FDA
FOIA
Hetlioz
Scorpion Stings Harmony with Citizen’s Petition Threat for Sleepiness Drug
BioSpace
Thu, 03/30/23 - 10:03 am
Harmony Biosciences
Scorpion Capital
FDA
Wakix
narcolepsy
citizen petitions
Otsuka, Lundbeck eye Alzheimer's indication in FDA adcomm for Rexulti label expansion
Endpoints
Thu, 03/30/23 - 10:02 am
Otsuka
Lundbeck
Alzheimer's disease
FDA
Rexulti
Alzheimer's disease agitation
The FDA may soon authorize a spring round of COVID-19 boosters for some people
NPR
Wed, 03/29/23 - 04:18 pm
FDA
vaccines
boosters
COVID-19
FDA greenlights Narcan for OTC use
Medical Marketing and Media
Wed, 03/29/23 - 04:14 pm
Narcan
Naloxone
OTC
FDA
Emergent BioSolutions
Bluebird to miss Q1 deadline for lovo-cel filing, shares sliced
Endpoints
Wed, 03/29/23 - 04:04 pm
Bluebird Bio
sickle cell disease
gene therapy
FDA
lovo-cel

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