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
Madrigal Pharmaceuticals completes $500M stock sale as it prepares for potential launch of NASH treatment
A decision from the FDA on Madrigal's new drug application for its experimental NASH therapy is expected in the spring. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 4, 2023 Category: Biotechnology Authors: John George 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
Montgomery County biopharma firm plans $500M stock offering while FDA reviews its NASH treatment application
A decision on the company's new drug application for its experimental NASH therapy is expected in the spring. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 29, 2023 Category: Biotechnology Authors: John George 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
