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FDA names chief scientist Bumpus as Woodcock’s successor

FDA names chief scientist Bumpus as Woodcock’s successor

BioPharma Dive

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

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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

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

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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

Duchenne Muscular Dystrophy

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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

acute radiation syndrome

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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

renal denervation

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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

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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

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Xtandi cleared by FDA for earlier-stage prostate cancer

Xtandi cleared by FDA for earlier-stage prostate cancer

Pharmaphorum

prostate cancer

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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

Stress Urinary Incontinence

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

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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

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

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

Turning Point Therapeutics

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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

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

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

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

product recalls

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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

cogenital thrombocytopenic purpura

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