Tag: Fast track

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Recent Related Articles to Fast track

Imaging Biometrics granted FDA “Fast-Track” - Investegate | Company Announcement

Added to Collection on: 2023-12-19 14:33:32

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Food and Drug Administration
Fast track
Glioblastoma
Imaging Biometrics LLC

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FDA Issues Draft Guidance on Its New Platform Technology Designation Program

Added to Collection on: 2024-06-12 17:22:48

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Food and Drug Administration
Biotechnology products
Drug safety
Drug development
Clinical research
New Drug Application
Center for Biologics Evaluation and Research
Biologics license application
Investigational New Drug
Biopharmaceutical
Approved drug
Fast track

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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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Lepu Biopharma Co., Ltd. Announces Breakthrough Therapy Designation Granted by the ...

Added to Collection on: 2024-08-06 00:12:28

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Food and Drug Administration
Pharmacy
Drug discovery
Breakthrough therapy
Fast track
Drug development
Nasopharyngeal carcinoma
Spectrum Pharmaceuticals
Friends of Cancer Research
Lepu Biopharma Co. Ltd.

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Neurogene Inc. Announces RMAT Designation for NGN-401 Investigational Gene Therapy ...

Added to Collection on: 2024-08-07 21:20:42

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Food and Drug Administration
Pharmacy
Pharmaceuticals policy
Regenerative Medicine Advanced Therapy
Priority review
Breakthrough therapy
Fast track
Accelerated approval
Clinical trial
Gene therapy
Helixmith
Neurogene Inc.
u.s. food and drug administration

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BridgeBio gets FDA RMAT designation for potential gene therapy

Added to Collection on: 2024-09-11 16:58:53

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Food and Drug Administration
Lipid storage disorders
Rare diseases
Pharmacy
Pharmaceuticals policy
Regenerative Medicine Advanced Therapy
Canavan disease
Gene therapy
Fast track
Therapy
BridgeBio Pharma

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FDA Grants Breakthrough Therapy Designation to Plozasiran for FCS - HCPLive

Added to Collection on: 2024-09-12 14:36:28

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Lipid metabolism disorders
Rare diseases
Apolipoprotein C-III
Apolipoproteins
Lipoprotein lipase deficiency
Breakthrough therapy
Hypertriglyceridemia
Chylomicron
Orphan drug
Hyperlipidemia
Fast track
Arrowhead Pharmaceuticals Inc.

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Longeveron® to Report Third Quarter 2024 Financial Results and Host Conference Call on ...

Added to Collection on: 2024-11-04 21:12:42

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Food and Drug Administration
Pharmaceuticals policy
Pharmacy
Regenerative Medicine Advanced Therapy
Regenerative biomedicine
Hypoplastic left heart syndrome
Fast track
Regenerative medicine
Alzheimer's disease
HLHS
Longeveron Inc.

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Rigel Announces R289 Granted Orphan Drug Designation by the FDA for MDS

Added to Collection on: 2025-01-09 15:36:29

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Food and Drug Administration
Pharmaceuticals policy
Drug discovery
Orphan drug
Fast track
Orphan Drug Act
Rigel Pharmaceuticals, Inc

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Branford biopharma firm Azitra prices $1.5M public stock offering | Hartford Business Journal

Added to Collection on: 2025-01-17 15:40:09

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Corporate finance
Equity securities
Stock market
Financial capital
Private equity
Stock
Biopharmaceutical
Fast track
Azitra Inc.

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