Tag: Priority review

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Recent Related Articles to Priority review

FDA Activity Recap: June 2024 Features Expanded Indication Approval, a CRL, RMAT ...

Added to Collection on: 2024-07-06 17:15:14

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Food and Drug Administration
Biotechnology
Pharmaceuticals policy
Pharmacy
Regenerative Medicine Advanced Therapy
Applied genetics
Sarepta Therapeutics
Gene therapy
Duchenne muscular dystrophy
Delandistrogene moxeparvovec
Priority review
Therapy

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Earnings call: Ultragenyx reports strong Q2 revenue, raises guidance - Investing.com

Added to Collection on: 2024-08-04 18:38:57

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Ultragenyx
Emil Kakkis
Orphan drugs
Priority review
Vestronidase alfa
Angelman syndrome
Ultragenyx Pharmaceutical Inc
Joshua Higa

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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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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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Opus Genetics Receives Rare Pediatric Disease Designation from the U.S. FDA for Ocular ...

Added to Collection on: 2024-08-20 18:06:53

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Gene delivery
Medical genetics
Molecular biology
Rare diseases
Blindness
Foundation Fighting Blindness
Gene therapy
Leber congenital amaurosis
Gene therapy of the human retina
Priority review
Retina
Voretigene neparvovec

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Neuren Pharmaceuticals (ASX:NEU): Another exciting chapter is yet to come with NNZ-2591

Added to Collection on: 2024-09-24 20:11:05

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Orphan drugs
Trofinetide
Acadia Pharmaceuticals
NNZ-2591
Priority review
Food and Drug Administration
Royalty payment
Neuren Pharmaceuticals

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Pharma Stock Roundup: FDA Approves SNY's Dupixent for COPD & More - October 4, 2024

Added to Collection on: 2024-10-05 06:31:20

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Antineoplastic drugs
Orphan drugs
Antibody-drug conjugates
Immunology
Cancer treatments
Trastuzumab deruxtecan
Sanofi
Regeneron Pharmaceuticals
Antibody-drug conjugate
Priority review
HER2
Dupilumab

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OS Therapies to Attend the 43rd Annual J.P. Morgan Healthcare Conference - BioSpace

Added to Collection on: 2025-01-02 17:46:13

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Breast cancer
Antineoplastic drugs
Immunology
HER2
Osteosarcoma
Priority review
Antibody-drug conjugate
OS Therapies Inc.

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Capricor Puts Rolling BLA for DMD Cardiomyopathy Cell Therapy Deramiocel in Front of the FDA

Added to Collection on: 2025-01-02 17:15:54

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Food and Drug Administration
Muscular dystrophy
Rare diseases
Duchenne muscular dystrophy
Regenerative Medicine Advanced Therapy
Priority review
Sarepta Therapeutics
Steve Wilton
CAP-1002
Capricor Therapeutics
Nippon Shinyaku
Capricor

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Goodwin's 2025 Rare Disease Symposium: Momentum Builds for Addressing Critical ...

Added to Collection on: 2025-02-26 18:00:24

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Food and Drug Administration
Priority review
Rare disease
Orphan drug
National Organization for Rare Disorders
Patient advocacy
Pharmaceutical industry
Orphan device
Food and Drug Administration Amendments Act

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