FDA

Pfizer's NASH Treatment Lands FDA Fast Track Designation
BioSpace
Thu, 05/26/22 - 10:44 pm
Pfizer
FDA
NASH
ervogastat/clesacostat
fast track
Novavax Readies COVID-19 Vaccine for FDA Advisory Committee Meeting
BioSpace
Thu, 05/26/22 - 10:55 am
Novavax
FDA
COVID-19
vaccines
NVS-CoV2373
Third FDA rejection for Verrica’s molluscum contagiosum drug
Pharmaforum
Thu, 05/26/22 - 10:49 am
Verrica Pharmaceuticals
FDA
molluscum contagiosum
VP-102
Medtech groups want more time to implement FDA’s QMSR rule
RAPS.org
Wed, 05/25/22 - 11:43 pm
devices
Medtech
FDA
QMSR
regulatory
FDA spells out the rules and restrictions for states seeking to import drugs from Canada
Endpoints
Wed, 05/25/22 - 11:35 pm
FDA
Canada
drug importation
Antios rocked as hepatitis B safety signal sparks clinical hold, termination of collaboration
Fierce Biotech
Wed, 05/25/22 - 10:34 am
Antios
hepatitis B
Assembly Biosciences
FDA
GSK 'schemed' FDA's drug-device approval pathway to deflect asthma inhaler generics, lawsuit claims
Fierce Pharma
Wed, 05/25/22 - 10:30 am
GSK
FDA
drug-device combos
Missouri
legal
asthma
inhalers
FDA approves Roivant drug, the first novel topical plaque psoriasis med in 25 years
MedCity News
Tue, 05/24/22 - 04:40 pm
Roivant
Vtama
FDA
psoriasis
plaque psoriasis
Pharma company continues its FDA lawsuit spree, this time after agency denies fast-track designation
Endpoints
Tue, 05/24/22 - 04:39 pm
FDA
Vanda Pharmaceuticals
fast track
tradipitant
CSL-UniQure Hemophilia B Gene Therapy Scores Priority Review
BioSpace
Tue, 05/24/22 - 04:34 pm
CSL Behring
uniQure
hemophilia B
gene therapy
FDA
priority review
etranacogene dezaparvovec
Nymox slumps as FDA rejects filing for prostate drug
Pharmaforum
Tue, 05/24/22 - 10:47 am
Nymox
FDA
benign prostatic hyperplasia
fexapotide triflutate
Pfizer spinout SpringWorks will ship its first drug to the FDA before year’s end with PhIII win
Endpoints
Tue, 05/24/22 - 10:46 am
Pfizer
SpringWorks Therapeutics
spinoffs
oncology
FDA
clinical trials
nirogacestat
desmoid tumors
AbbVie adds to Vraylar data as FDA considers depression use
Pharmaforum
Tue, 05/24/22 - 10:43 am
AbbVie
Vraylar
FDA
clinical trials
treatment-resistant depression
FDA advisory panel to meet June 15 to discuss Pfizer, BioNTech and Moderna vaccines for children aged 6 months to 4 years
Marketwatch
Tue, 05/24/22 - 10:41 am
COVID-19
Pfizer
BioNTech
FDA
vaccines
Moderna Therapeutics
pediatric
Bristol Myers dusts off an old Celgene chemotherapy for use in children with a rare blood cancer
Endpoints
Mon, 05/23/22 - 06:51 pm
Bristol Myers Squibb
Celgene
chemotherapy
FDA
Vidaza
MDS
What FDA’s New Machine Learning Guiding Principles Really Mean
Medical Devices and Diagnostics Industry
Mon, 05/23/22 - 06:49 pm
FDA
regulatory
machine learning
artificial intelligence
Pfizer/BioNTech to seek Covid vaccine authorization for children under age 5
Stat
Mon, 05/23/22 - 10:39 am
Pfizer
BioNTech
COVID-19
vaccines
pediatric
FDA
'I really don’t look back': Janet Woodcock on her transition away from drugs
Endpoints
Mon, 05/23/22 - 10:27 am
FDA
Janet Woodcock
FDA lifts hold on Ocugen's COVID-19 vaccine trial. But is it too late for the shot?
Fierce Pharma
Mon, 05/23/22 - 10:14 am
Ocugen
FDA
clinical hold
vaccines
COVID-19
Covaxin
Sanofi's Dupixent scores big as the first FDA-approved treatment for eosinophilic esophagitis
Fierce Pharma
Sun, 05/22/22 - 09:15 pm
Sanofi
Regeneron
Dupixent
FDA
eosinophilic esophagitis

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