FDA

FDA Lifts Partial Clinical Hold On Bluebird Bio's Sickle Cell Disease Studies
NASDAQ
Mon, 12/19/22 - 10:59 am
Bluebird Bio
FDA
clinical trials
lovo-cel
sickle cell disease
Diamyd Diabetes Vaccine Study gets Green Light to Resume by the FDA
Xtalks
Thu, 12/15/22 - 11:07 pm
Diamyd Medical
type 1 diabetes
FDA
clinical trials
Diamyd
Federal Circuit court halts delisting of Jazz narcolepsy drug patent from the Orange Book
Endpoints
Thu, 12/15/22 - 11:04 pm
legal
Orange Book
Jazz Pharma
FDA
patents
narcolepsy
Xyrem
AstraZeneca, Merck hit with 3-month delay for Lynparza's FDA filing in first-line prostate cancer
Fierce Pharma
Thu, 12/15/22 - 11:01 am
AstraZeneca
Merck
Lynparza
FDA
metastatic castration-resistant prostate cancer
FDA says yes to MedCognetics breast cancer screening AI
Pharmaphorum
Thu, 12/15/22 - 10:53 am
Medtech
digital health
MedCognetics
FDA
artificial intelligence
breast cancer
diagnostics
FDA Approval of Mirati Lung Cancer Drug Sets Stage for Competition With Amgen
MedCity News
Wed, 12/14/22 - 10:19 am
Amgen
Mirati Therapeutics
Krazati
Lumakras
FDA
lung cancer
FDA advisers nix Cytokinetics' heart failure med, rejecting argument for subgroup use
Fierce Biotech
Tue, 12/13/22 - 11:56 pm
FDA
Cytokinetics
heart failure
Omecamtiv Mecarbil
Roche wins earlier-than-expected approval for blockbuster Tecentriq in rare soft tissue cancer
Endpoints
Tue, 12/13/22 - 11:50 pm
Roche
Tecentriq
FDA
soft tissue cancer
Bags of shredded docs: Indian drugmaker Lupin handed a Form 483 by FDA inspectors
Endpoints
Sun, 12/11/22 - 01:29 pm
Lupin
generics
regulatory
FDA
inspections
Ahead of adcomm, FDA raises uncertainties on benefit-risk profile of Cytokinetics' potential heart drug
Endpoints
Sun, 12/11/22 - 01:28 pm
FDA
Cytokinetics
heart failure
Omecamtiv Mecarbil
FDA Questions Lasik Informed Consent, Industry Says ‘Step Off’
Medical Devices and Diagnostics Industry
Sun, 12/11/22 - 01:24 pm
Medtech
FDA
Lasik
informed consent
Broken promises? FDA needs more power to remove drugs from marketplace, JAMA analysis finds
Endpoints
Sun, 12/11/22 - 01:22 pm
JAMA
FDA
clinical trials
FDA halts imports of several Sun Pharma drugs made in India due to outstanding quality issues
Endpoints
Fri, 12/9/22 - 10:27 am
Sun Pharma
India
FDA
drug importation
FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors
RAPS.org
Thu, 12/8/22 - 11:21 pm
FDA
PD-1/L1 therapy
regulatory
FDA commissioner on drug approvals: The problem isn't innovation or speed
Endpoints
Thu, 12/8/22 - 11:15 pm
FDA
Robert Califf
innovation
drug approvals
AdvaMed asks FDA to withdraw divisive draft guidance on LASIK surgery
Medtech Dive
Thu, 12/8/22 - 10:21 am
AdvaMed
Medtech
Lasik
FDA
FDA authorizes Moderna, Pfizer updated COVID boosters for 6 months old
Yahoo/Reuters
Thu, 12/8/22 - 10:06 am
Pfizer
BioNTech
Moderna Therapeutics
FDA
COVID-19
vaccines
infants
pediatric
FDA looks to pull approval for Oncopeptides' troubled multiple myeloma drug Pepaxto
Fierce Pharma
Thu, 12/8/22 - 10:01 am
Oncopeptides
Multiple Myeloma
Pepaxto
FDA
Pfizer's RSV vaccine rush gets FDA boost with priority review
Fierce Biotech
Wed, 12/7/22 - 11:45 pm
Pfizer
RSV
vaccines
FDA
priority review
RSVpreF
Rigel’s Rezlidhia (olutasidenib) Gets FDA Approval for Relapsed or Refractory AML
Xtalks
Wed, 12/7/22 - 09:53 am
Rigel Pharmaceuticals
Rezlidhia
olutasidenib
FDA
AML

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