FDA

US FDA clears Vivos Therapeutics' oral device for sleep apnea
Reuters
Thu, 11/30/23 - 10:17 am
Medtech
Vivos Therapeutics
obstructive sleep apnea
FDA
BiVACOR wins IDE to start first-in-human study for artificial heart
Clinical Trials Arena
Thu, 11/30/23 - 10:06 am
BiVACOR
FDA
IDE
Medtech
Artificial Heart
FDA names chief scientist Bumpus as Woodcock’s successor
BioPharma Dive
Wed, 11/29/23 - 12:08 pm
FDA
regulatory
Janet Woodcock
Namandjé Bumpus
FDA Launches Probe of Malignancies Linked to CAR-T Therapies
BioSpace
Wed, 11/29/23 - 12:04 pm
CAR-T
side effects
FDA
FDA Rejects Aldeyra’s Dry Eye Drug, Cites Need for Additional Trial
BioSpace
Wed, 11/29/23 - 12:03 pm
Aldeyra Therapeutics
reproxalap
FDA
dry eye disease
FDA kicks off review of Karuna’s schizophrenia drug KarXT
Pharmaphorum
Wed, 11/29/23 - 11:57 am
Karuna
KarXT
FDA
schizophrenia
FDA rebuffs Entrada's attempt to get yearlong hold on DMD drug lifted
Fierce Biotech
Wed, 11/22/23 - 12:03 pm
Entrada Therapeutics
FDA
Duchenne Muscular Dystrophy
ENTR-601-44
NeoImmuneTech receives orphan drug status for NT-I7 to treat ARS
Pharmaceutical Business Review
Tue, 11/21/23 - 11:59 am
NeoImmune Tech
FDA
NT-I7
acute radiation syndrome
orphan drugs
Medtronic Finally Wins the Big One for Symplicity RDN Treatment
Medical Devices and Diagnostics Industry
Mon, 11/20/23 - 09:32 pm
Medtronic
Medtech
Symplicity
FDA
renal denervation
hypertension
FDA to delay decision on Bristol Myers-2seventy bio cancer therapy
Reuters
Mon, 11/20/23 - 10:12 am
Bristol Myers Squibb
2seventy bio
blood cancer
FDA
Abecma
FDA panel flags insufficient data for Merck's chronic cough drug
Reuters
Sun, 11/19/23 - 09:32 pm
Merck
FDA
chronic cough
gefapixant
Xtandi cleared by FDA for earlier-stage prostate cancer
Pharmaphorum
Fri, 11/17/23 - 10:10 am
Pfizer
Astellas
Xtandi
prostate cancer
FDA
FDA approves study of Versameb’s mRNA therapy in urinary incontinence
Clinical Trials Arena
Fri, 11/17/23 - 10:03 am
Versameb
MRNA
Stress Urinary Incontinence
FDA
clinical trials
Top FDA official Woodcock to retire early next year
BioPharma Dive
Thu, 11/16/23 - 10:20 pm
FDA
Janet Woodcock
Valneva single-dose chikungunya vaccine poised to ‘revolutionize’ global health
Biopharma Reporter
Thu, 11/16/23 - 11:38 am
Valneva
vaccines
Ixchiq
FDA
chikungunya virus
Astellas Sees Path Forward for Gene Therapy Despite Four Patient Deaths
BioSpace
Thu, 11/16/23 - 11:36 am
Astellas
AT132
patient deaths
FDA
X-linked myotubular myopathy
BMS gets US approval for ROS1 lung cancer drug Augtyro
Pharmaphorum
Thu, 11/16/23 - 10:11 am
Bristol Myers Squibb
Augtyro
Turning Point Therapeutics
lung cancer
FDA
CorMedix gains hard-fought approval for combo drug that reduces risk of catheter infection during dialysis
Fierce Pharma
Wed, 11/15/23 - 11:43 pm
CorMedix
FDA
DefenCath
dialysis
catheter infections
FDA's oncology office uses advisory committee to spotlight timely accelerated approval confirmation
Fierce Pharma
Wed, 11/15/23 - 11:20 am
FDA
regulatory
oncology
cancer
accelerated approvals
Acrotech Biopharma
FDA rules Otsuka marketing claim overstates Rexulti efficacy, threatening cornerstone of huge TV push
Fierce Pharma
Tue, 11/14/23 - 11:19 am
Otsuka
FDA
Rexulti
pharma marketing
clinical depression

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