Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil
Submission seeks approval for treatment of an abnormal heart rhythm, Paroxysmal Supraventricular Tachycardia or PSVT
Comprehensive data package includes positive results from pivotal Phase 3 RAPID trial which Company believes demonstrates... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 24, 2023 Category: Drugs & Pharmacology Source Type: news
Sun Pharma Announces US FDA Filing Acceptance of New Drug Application for Deuruxolitinib
Mumbai, INDIA and Princeton, N.J., October 06, 2023– Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715,“Sun Pharma” and includes its subsidiaries or associate companies) today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 6, 2023 Category: Drugs & Pharmacology Source Type: news
Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for Udenyca ® OnBody™
REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced the Company has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, the company ' s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 5, 2023 Category: Drugs & Pharmacology Source Type: news
Basilea Announces FDA Acceptance of New Drug Application for Antibiotic Ceftobiprole
Seeking approval for Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP)
Prescription Drug User Fee Act (PDUFA) goal date set for April 03,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 2, 2023 Category: Drugs & Pharmacology Source Type: news
Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review
TARRYTOWN, N.Y., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 29, 2023 Category: Drugs & Pharmacology Source Type: news
Karuna Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KarXT for the Treatment of Schizophrenia
BOSTON--(BUSINESS WIRE)--Sep. 28, 2023-- Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 28, 2023 Category: Drugs & Pharmacology Source Type: news
Akebia Therapeutics Resubmits New Drug Application to the FDA for Vadadustat
CAMBRIDGE, Mass., Sept. 28, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced it has resubmitted its New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 28, 2023 Category: Drugs & Pharmacology Source Type: news
Alpha Cognition Announces Submission of New Drug Application to the FDA for ALPHA-1062 for Mild-to-Moderate Alzheimer ’s Disease
VANCOUVER, B.C., September 27, 2023. Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition“ACI”, or the“Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 27, 2023 Category: Drugs & Pharmacology Source Type: news
Abeona Therapeutics Submits Biologics License Application to U.S. FDA Seeking Priority Review and Approval of EB-101 for the Treatment of Patients with Recessive Dystrophic Epidermolysis Bullosa
CLEVELAND, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of EB-101, its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Accepts Defender Pharmaceuticals ’ New Drug Application for Intranasal Scopolamine Gel
ST. LOUIS, MO—(BUSINESS WIRE)—September Sep. 26, 23—Defender Pharmaceuticals, Inc. (the“Company” or“Defender”), a privately held life sciences company based in St. Louis, today announced that the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Accepts Submission to Add PH-ILD to Yutrepia ™ Label
MORRISVILLE, N.C., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s amendment to the tentatively approved... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 25, 2023 Category: Drugs & Pharmacology Source Type: news
Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)
OSAKA, Japan and CAMBRIDGE, Massachusetts, September 20, 2023– Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 20, 2023 Category: Drugs & Pharmacology Source Type: news
UCB Provides Update on U.S. Regulatory Review of Bimekizumab
Brussels (Belgium), 19 September 2023– UCB, a global biopharmaceutical company, today provided an update on the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.
UCB has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 19, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Issues Complete Response Letter for neffy ® (epinephrine nasal spray) New Drug Application with Request for Additional Study
Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions
FDA Advisory Committee (PADAC), held in May 2023,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 19, 2023 Category: Drugs & Pharmacology Source Type: news
Orexo Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Overdose
OX124 is based on Orexo´s world-class drug delivery platform amorphOX® and is designed to reverse the effect of the most powerful synthetic opioids, such as fentanyl
Synthetic opioids are behind 91 percent of all fatal opioid overdoses... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 19, 2023 Category: Drugs & Pharmacology Source Type: news
