Reata Pharmaceuticals Announces FDA Filing Acceptance and Priority Review Designation for the NDA for Omaveloxolone for the Treatment of Patients with Friedreich ’s Ataxia
Friedreich’s Ataxia is a Rare, Progressive, Life-Shortening, Neuromuscular Disease that Affects Approximately 5,000 Patients in the United States
Application Assigned a PDUFA Date of November 30, 2022
If Approved, Omaveloxolone Would... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 26, 2022 Category: Drugs & Pharmacology Source Type: news
Phathom Pharmaceuticals Announces FDA Acceptance for Filing of Vonoprazan NDA for the Treatment of Erosive Esophagitis
FLORHAM PARK, N.J., May 25, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 25, 2022 Category: Drugs & Pharmacology Source Type: news
Verrica Receives Complete Response Letter from the FDA for its NDA for VP-102
Verrica has been advised that PAI (Pre-Approval Inspection) was conducted at Sterling and is not aware of any reported observations related to the PAI of VP-102 operations
Review Division had advised Verrica that the review of NDA was completed... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 24, 2022 Category: Drugs & Pharmacology Source Type: news
US FDA Accepts for Review Biohaven's New Drug Application (NDA) Filing of Intranasal Zavegepant for the Treatment of Migraine
If approved, zavegepant nasal spray would be the only FDA-approved CGRP receptor antagonist in an intranasal formulation, giving patients a new treatment option that provides ultra-rapid pain relief in as little as 15 minutes that lasts... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 23, 2022 Category: Drugs & Pharmacology Source Type: news
ImmunoGen Announces Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer by US Food and Drug Administration with Priority Review
WALTHAM, Mass.--(BUSINESS WIRE)-- May 23, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 23, 2022 Category: Drugs & Pharmacology Source Type: news
AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson's Disease
If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs
Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of " On " time without... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 20, 2022 Category: Drugs & Pharmacology Source Type: news
Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil
SOUTH SAN FRANCISCO, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the Company recently participated in a mid-cycle communication meeting with the U.S. Food& Drug Administration (FDA) and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 17, 2022 Category: Drugs & Pharmacology Source Type: news
Travere Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Sparsentan for the Treatment of IgA Nephropathy
PDUFA target action date of November 17, 2022
SAN DIEGO, May 16, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of its New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 16, 2022 Category: Drugs & Pharmacology Source Type: news
scPharmaceuticals Inc. Announces FDA Acceptance of Furoscix New Drug Application
PDUFA action date set for October 8, 2022
BURLINGTON, Mass., May 16, 2022 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 16, 2022 Category: Drugs & Pharmacology Source Type: news
Update on U.S. FDA Review of Biologics License Application (BLA) for Bimekizumab - Complete Response Letter
Brussels (Belgium), 13th May 2022 – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 13, 2022 Category: Drugs & Pharmacology Source Type: news
Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer ’s Disease Under the Accelerated Approval Pathway
TOKYO and CAMBRIDGE, Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, " Eisai " ) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, May 9, 2022 -- CEO: Michel Vounatsos, " Biogen " ) announced today that Eisai has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 9, 2022 Category: Drugs & Pharmacology Source Type: news
Hutchmed Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Hong Kong, Shanghai& Florham Park, NJ— Monday, May 2, 2022: Hutchmed (China) Limited (“Hutchmed” or the“Company”) (Nasdaq/AIM:HCM; HKEX:13) announced that the U.S. Food and Drug Administration (“FDA”... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 4, 2022 Category: Drugs & Pharmacology Source Type: news
Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)
The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023
CAMBRIDGE, Mass.– May 2, 2022– Sage... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 2, 2022 Category: Drugs & Pharmacology Source Type: news
Coherus and Junshi Biosciences Receive Complete Response Letter from U.S. FDA for Toripalimab BLA
The CRL requests a quality process change Coherus and Junshi believe is readily addressable
BLA resubmission anticipated by mid-summer 2022 with expected six month FDA review timeline
Onsite inspections in China, impeded to date by... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 2, 2022 Category: Drugs & Pharmacology Source Type: news
Axsome Therapeutics Receives FDA Complete Response Letter for New Drug Application for AXS-07 for the Acute Treatment of Migraine
No clinical efficacy or safety issues raised and no additional clinical studies required by FDA to support approval
Company plans to engage with FDA toward expeditious resolution of outstanding items
NEW YORK, May 2, 2022 /PRNewswire/ --... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 2, 2022 Category: Drugs & Pharmacology Source Type: news
