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

Topical Treatment for EB Recommended for Approval in the EU Topical Treatment for EB Recommended for Approval in the EU
In February, the FDA declined to approve the company ' s new drug application as it was presented and asked the company to submit additional evidence of effectiveness for epidermolysis bullosa (EB).International Approvals (Source: Medscape Dermatology Headlines)
Source: Medscape Dermatology Headlines - April 27, 2022 Category: Dermatology Tags: Dermatology News Alert Source Type: news

Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for Pedmark
Prescription Drug User Fee Act (PDUFA) target action date set for September 23, 2022 RESEARCH TRIANGLE PARK, N.C., , April 27, 2022 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 27, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Rejects Schizophrenia Tx; ADHD & Mental Health; Eating Disorder Treatment Scarce
(MedPage Today) -- The FDA hit Teva Pharmaceuticals and MedinCell with a complete response letter in regard to their new drug application for the schizophrenia treatment TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous... (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - April 20, 2022 Category: Psychiatry Source Type: news

Alembic gets USFDA nod to market generic drug
The company has received tentative approval from the US Food& Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for lvabradine tablets (5 mg and 7.5 mg), Alembic Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 20, 2022 Category: Pharmaceuticals Source Type: news

US Food and Drug Administration Accepts New Drug Application for Daprodustat
Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND phase III clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 19, 2022 Category: Drugs & Pharmacology Source Type: news

Research Investigational New Drug Applications – What You Need To Know
FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 19, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

The ABCs of Product-Specific Guidances | Audio Transcript
PSGs help streamline generic drug product development, promoting timely approval of abbreviated new drug application, or ANDA, submissions and increasing drug competition, ultimately improving patient access to high quality and affordable medicines. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 18, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news