Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA
TOKYO& BASKING RIDGE, N.J.--(BUSINESS WIRE)-- April 21, 2023 -- Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 21, 2023 Category: Drugs & Pharmacology Source Type: news
Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for Xphozah (tenapanor)
WALTHAM, Mass., April 18, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 18, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab
INDIANAPOLIS, April 13, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 13, 2023 Category: Drugs & Pharmacology Source Type: news
HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
Hong Kong, Shanghai& Florham Park, NJ— Friday March 31, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX:13) today announces that it completed the rolling submission of a New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 31, 2023 Category: Drugs & Pharmacology Source Type: news
Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS
CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 23, 2023 Category: Drugs & Pharmacology Source Type: news
AbbVie Provides Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) New Drug Application
NORTH CHICAGO, Ill., March 22, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 22, 2023 Category: Drugs & Pharmacology Source Type: news
Ionis Announces FDA Acceptance of New Drug Application for Eplontersen for the Treatment of Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN)
35-week data included in the filing demonstrated a statistically significant and clinically meaningful change from baseline for co-primary and secondary endpoints compared to external placebo group
Eplontersen previously granted Orphan Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 7, 2023 Category: Drugs & Pharmacology Source Type: news
Avadel Pharmaceuticals Requests Final FDA Approval for Lumryz (sodium oxybate) Extended-Release Oral Suspension
DUBLIN, Ireland, March 02, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it has submitted an amendment to the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Accepts for Priority Review ADX-2191 New Drug Application for the Treatment of Primary Vitreoretinal Lymphoma
LEXINGTON, Mass.--(BUSINESS WIRE) March 2, 2023 --Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the New Drug Application (NDA) for ADX-2191... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2023 Category: Drugs & Pharmacology Source Type: news
Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil
SOUTH SAN FRANCISCO, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 28, 2023 Category: Drugs & Pharmacology Source Type: news
Verrica Pharmaceuticals Announces FDA Acceptance of Filing of Resubmitted NDA for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, PA– February 27, 2023 (GLOBE NEWSWIRE)– Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2023 Category: Drugs & Pharmacology Source Type: news
Pfizer ’s Elranatamab Receives FDA and EMA Filing Acceptance
NEW YORK--(BUSINESS WIRE) February 22, 2023 -- Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 22, 2023 Category: Drugs & Pharmacology Source Type: news
Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease Accepted for FDA Priority Review
If approved, pozelimab would be the first and only treatment for those living with CHAPLE
CHAPLE is an ultra-rare hereditary immune disease that causes overactivation of the complement system, leading to potentially life-threatening abdominal and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 21, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Accepts Orasis Pharmaceuticals ’ New Drug Application for CSF-1 for the Treatment of Presbyopia
Investigational, novel eye drop candidate was assigned PDUFA goal date of October 22, 2023
Ponte Vedra, FL, February 21, 2023– Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 21, 2023 Category: Drugs & Pharmacology Source Type: news
Astellas Provides Update on Fezolinetant New Drug Application in U.S.
TOKYO, Feb. 19, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 20, 2023 Category: Drugs & Pharmacology Source Type: news
