Ocuphire Pharma Announces Submission of New Drug Application to FDA for Nyxol Eye Drops for Reversal of Mydriasis
NDA Supported by Positive Phase 3 Data Demonstrating Rapid Reversal of Dilated Eyes and Favorable Safety Profile in Pediatric and Adult Subjects
FARMINGTON HILLS, Mich., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 6, 2022 Category: Drugs & Pharmacology Source Type: news
Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 29, 2022-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 29, 2022 Category: Drugs & Pharmacology Source Type: news
Sarepta Therapeutics Announces That U.S. FDA has Accepted for Filing and Granted Priority Review for the Biologics License Application for SRP-9001, Sarepta ’s Gene Therapy for the Treatment of Ambulant Individuals with Duchenne Muscular Dystrophy
Regulatory action date of May 29, 2023
SRP-9001 would be the first gene therapy for Duchenne, a one-time treatment designed to treat the underlying cause of DMD by delivering a functional shortened dystrophin to muscle
CAMBRIDGE, Mass., Nov.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 28, 2022 Category: Drugs & Pharmacology Source Type: news
Spectrum Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Poziotinib
Immediately de-prioritizes poziotinib program, accelerates cost reductions, including 75% reduction in R&D related workforce
Spectrum to explore strategic alternatives for the poziotinib program, including partnerships and business... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 25, 2022 Category: Drugs & Pharmacology Source Type: news
GSK Provides an Update on Blenrep (belantamab mafodotin-blmf) US Marketing Authorization
London, UK, 22 November 2022 -- GSK plc (LSE/NYSE: GSK) today announced it has initiated the process for withdrawal of the US marketing authorization for Blenrep following the request of the US Food and Drug Administration (FDA). This request was... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 22, 2022 Category: Drugs & Pharmacology Source Type: news
Opiant Pharmaceuticals Announces Completion of Rolling NDA Submission for OPNT003, Nasal Nalmefene, for Opioid Overdose
SANTA MONICA, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 22, 2022 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Accepts for Priority Review the Biologics License Application for Epcoritamab (DuoBody ®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma
The application is supported by data from EPCORE™ NHL-1 Phase 1/2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin ' s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 21, 2022 Category: Drugs & Pharmacology Source Type: news
Iovance Biotherapeutics Provides Update on Biologics License Application Submission for Lifileucel in Advanced Melanoma
BLA Submission Ongoing with U.S. Food and Drug Administration
SAN CARLOS, Calif., Nov. 18, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) today announced that its ongoing rolling Biologics License Application (BLA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 18, 2022 Category: Drugs & Pharmacology Source Type: news
Iveric Bio Announces FDA Has Granted Breakthrough Therapy Designation for Avacincaptad Pegol for Geographic Atrophy
Designation based on 12-month primary endpoint data from GATHER pivotal trials
Avacincaptad pegol (ACP) is the only investigational product for treatment of GA to achieve two positive phase 3 pivotal trials with statistical significance
In... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 17, 2022 Category: Drugs & Pharmacology Source Type: news
UCB Announces U.S. FDA Acceptance of New Drug Application and EMA MAA Validation for Zilucoplan for the Treatment of Generalized Myasthenia Gravis in Adult Patients
New drug application (NDA) for zilucoplan seeks approval for the treatment of generalized myasthenia gravis (gMG) in adult patients who are acetylcholine receptor antibody positive (AChR-Ab+)
Acceptance by U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 14, 2022 Category: Drugs & Pharmacology Source Type: news
Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson ’s Disease
IPX203 could offer people living with Parkinson’s disease a longer duration of symptom control with less frequent dosing compared to IR CD/LD treatment
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 30,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 11, 2022 Category: Drugs & Pharmacology Source Type: news
BioLineRx Announces U.S. FDA Acceptance of New Drug Application for Aphexda (motixafortide) in Stem Cell Mobilization
PDUFA target action date set for September 9, 2023
NDA submission based on GENESIS Phase 3 trial data that met all primary and secondary endpoints with a high level of statistical significance
Company advancing preparations for robust commercial... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 10, 2022 Category: Drugs & Pharmacology Source Type: news
Iveric Bio Announces Submission of First Part of NDA for Rolling Review of Avacincaptad Pegol for the Treatment of Geographic Atrophy
PARSIPPANY, N.J.--(BUSINESS WIRE)--Nov. 3, 2022-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the first part of its New Drug Application (NDA) for rolling review of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 3, 2022 Category: Drugs & Pharmacology Source Type: news
Genmab Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody ®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL) and Diffuse Large B-Cell Lymphoma (DLBCL)
Genmab has Submitted Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) for epcoritamab
European Medicines Agency (EMA) has validated Marketing Authorization Application (MAA) for epcoritamab submitted by AbbVie
The... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 28, 2022 Category: Drugs & Pharmacology Source Type: news
Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, October 27, 2022– Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that they have completed the rolling submission of a new drug application (NDA) to the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 27, 2022 Category: Drugs & Pharmacology Source Type: news
