Tag: Prescription Drug User Fee Act

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Recent Related Articles to Prescription Drug User Fee Act

The FDA's Present and Future, with Commissioner Robert Califf, MD - HCPLive

Added to Collection on: 2022-12-23 17:04:27

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Health
Articles
Food and Drug Administration
Life Sciences
Pharmaceuticals policy
Pharmaceutical industry
Drug discovery
Pharmacy
Fast track
Prescription Drug User Fee Act
Priority review
Accelerated approval
United States

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5 Key FDA Decisions Expected in the First Quarter of 2023 - HCPLive

Added to Collection on: 2022-12-31 20:23:49

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Branches of biology
Health
Medicine
RTT
Breakthrough therapy
Food and Drug Administration
Aflibercept
Bayer AG
Anti–vascular endothelial growth factor therapy
Prescription Drug User Fee Act
Macular edema
Diabetic retinopathy

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Regeneron's bispecific lymphoma antibody odronextamab wins FDA priority review

Added to Collection on: 2023-09-30 00:33:25

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Antineoplastic drugs
Orphan drugs
Breakthrough therapy
Lymphoma
Cancer immunotherapy
Diffuse large B-cell lymphoma
Regeneron Pharmaceuticals
Food and Drug Administration
Prescription Drug User Fee Act
B-cell maturation antigen
Pembrolizumab
Umbralisib

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Bristol Myers Squibb Takes Over Karuna Therapeutics - CHEManager

Added to Collection on: 2023-12-23 22:22:21

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Muscarinic agonists
KarXT
Xanomeline
Bristol-Myers Squibb
Prescription Drug User Fee Act
Trospium chloride
Antipsychotic

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Astellas Provides Update on Zolbetuximab Biologics License Application in U.S. | Antibodies

Added to Collection on: 2024-01-09 15:19:16

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Food and Drug Administration
Astellas Pharma
Mitsubishi UFJ Financial Group
Monoclonal antibodies
Zolbetuximab
CLDN18
Prescription Drug User Fee Act
Biologics license application
u.s. food and drug administration
Astellas Pharma Inc.

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PDUFA Date Coming Up for U.K. Biopharma - The Streetwise Reports

Added to Collection on: 2024-04-23 09:03:57

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Food and Drug Administration
Pharmaceuticals policy
Canaccord Genuity
Genuity
Prescription Drug User Fee Act
Securities research
Financial Industry Regulatory Authority
Financial analyst
Investment banking
PDUFA date
Pharmaceutical industry in China
Chronic obstructive pulmonary disease
United Kingdom
Verona Pharma plc
u.s. food and drug administration

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FDA accepts filing of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the ...

Added to Collection on: 2024-06-10 04:43:58

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Alzheimer's disease
Amyloidosis
Lecanemab
Food and Drug Administration
Eisai
Prescription Drug User Fee Act
Amyloid beta
BioArctic AB
STOCKHOLM
u.s. food and drug administration

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Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA's Regenerative ...

Added to Collection on: 2024-07-01 15:58:48

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Food and Drug Administration
Pharmaceuticals policy
Pharmacy
Regenerative Medicine Advanced Therapy
Forward-looking statement
Peripheral artery disease
Fast track
Tissue engineering
Prescription Drug User Fee Act
Tissue-type plasminogen activator
humacyte, inc.

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CGTLive®'s Weekly Rewind – July 26, 2024

Added to Collection on: 2024-07-26 19:08:34

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Food and Drug Administration
Regenerative biomedicine
Pharmaceuticals policy
Mesoblast
Prescription Drug User Fee Act

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Humacyte Announces FDA Communication of Additional Time Required to Complete ... - Stock Titan

Added to Collection on: 2024-08-10 08:17:50

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Food and Drug Administration
Prescription Drug User Fee Act
PDUFA date
Priority review
Biologics license application
humacyte, inc.
Ukraine

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