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FDA
FDA names chief scientist Bumpus as Woodcock’s successor
FDA names chief scientist Bumpus as Woodcock’s successor
BioPharma Dive
FDA
regulatory
Janet Woodcock
Namandjé Bumpus
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FDA Launches Probe of Malignancies Linked to CAR-T Therapies
FDA Launches Probe of Malignancies Linked to CAR-T Therapies
BioSpace
CAR-T
side effects
FDA
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FDA Rejects Aldeyra’s Dry Eye Drug, Cites Need for Additional Trial
FDA Rejects Aldeyra’s Dry Eye Drug, Cites Need for Additional Trial
BioSpace
Aldeyra Therapeutics
reproxalap
FDA
dry eye disease
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FDA kicks off review of Karuna’s schizophrenia drug KarXT
FDA kicks off review of Karuna’s schizophrenia drug KarXT
Pharmaphorum
Karuna
KarXT
FDA
schizophrenia
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FDA rebuffs Entrada's attempt to get yearlong hold on DMD drug lifted
FDA rebuffs Entrada's attempt to get yearlong hold on DMD drug lifted
Fierce Biotech
Entrada Therapeutics
FDA
Duchenne Muscular Dystrophy
ENTR-601-44
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NeoImmuneTech receives orphan drug status for NT-I7 to treat ARS
NeoImmuneTech receives orphan drug status for NT-I7 to treat ARS
Pharmaceutical Business Review
NeoImmune Tech
FDA
NT-I7
acute radiation syndrome
orphan drugs
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Medtronic Finally Wins the Big One for Symplicity RDN Treatment
Medtronic Finally Wins the Big One for Symplicity RDN Treatment
Medical Devices and Diagnostics Industry
Medtronic
Medtech
Symplicity
FDA
renal denervation
hypertension
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FDA to delay decision on Bristol Myers-2seventy bio cancer therapy
FDA to delay decision on Bristol Myers-2seventy bio cancer therapy
Reuters
Bristol Myers Squibb
2seventy bio
blood cancer
FDA
Abecma
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FDA panel flags insufficient data for Merck's chronic cough drug
FDA panel flags insufficient data for Merck's chronic cough drug
Reuters
Merck
FDA
chronic cough
gefapixant
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Xtandi cleared by FDA for earlier-stage prostate cancer
Xtandi cleared by FDA for earlier-stage prostate cancer
Pharmaphorum
Pfizer
Astellas
Xtandi
prostate cancer
FDA
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FDA approves study of Versameb’s mRNA therapy in urinary incontinence
FDA approves study of Versameb’s mRNA therapy in urinary incontinence
Clinical Trials Arena
Versameb
MRNA
Stress Urinary Incontinence
FDA
clinical trials
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Top FDA official Woodcock to retire early next year
Top FDA official Woodcock to retire early next year
BioPharma Dive
FDA
Janet Woodcock
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Valneva single-dose chikungunya vaccine poised to ‘revolutionize’ global health
Valneva single-dose chikungunya vaccine poised to ‘revolutionize’ global health
Biopharma Reporter
Valneva
vaccines
Ixchiq
FDA
chikungunya virus
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Astellas Sees Path Forward for Gene Therapy Despite Four Patient Deaths
Astellas Sees Path Forward for Gene Therapy Despite Four Patient Deaths
BioSpace
Astellas
AT132
patient deaths
FDA
X-linked myotubular myopathy
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BMS gets US approval for ROS1 lung cancer drug Augtyro
BMS gets US approval for ROS1 lung cancer drug Augtyro
Pharmaphorum
Bristol Myers Squibb
Augtyro
Turning Point Therapeutics
lung cancer
FDA
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CorMedix gains hard-fought approval for combo drug that reduces risk of catheter infection during dialysis
CorMedix gains hard-fought approval for combo drug that reduces risk of catheter infection during dialysis
Fierce Pharma
CorMedix
FDA
DefenCath
dialysis
catheter infections
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FDA's oncology office uses advisory committee to spotlight timely accelerated approval confirmation
FDA's oncology office uses advisory committee to spotlight timely accelerated approval confirmation
Fierce Pharma
FDA
regulatory
oncology
cancer
accelerated approvals
Acrotech Biopharma
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FDA rules Otsuka marketing claim overstates Rexulti efficacy, threatening cornerstone of huge TV push
FDA rules Otsuka marketing claim overstates Rexulti efficacy, threatening cornerstone of huge TV push
Fierce Pharma
Otsuka
FDA
Rexulti
pharma marketing
clinical depression
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FDA Deems Recall of Stolen Medtronic Laryngoscopes as Class I
FDA Deems Recall of Stolen Medtronic Laryngoscopes as Class I
Medical Devices and Diagnostics Industry
Medtech
Medtronic
laryngoscopes
product recalls
device recalls
FDA
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Takeda Wins First FDA Approval for Ultra-Rare Blood Clotting Disease
Takeda Wins First FDA Approval for Ultra-Rare Blood Clotting Disease
BioSpace
Takeda
FDA
ADAMTS13
Adzynma
cogenital thrombocytopenic purpura
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