Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam
Malvern, PA, and Parsippany, NJ– February 23, 2024– Venatorx Pharmaceuticals (Venatorx) and Melinta Therapeutics (Melinta) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 23, 2024 Category: Drugs & Pharmacology Source Type: news

Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review
TARRYTOWN, N.Y., Feb. 21, 2024 (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 - February 21, 2024 Category: Drugs & Pharmacology Source Type: news

FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-mutant diffuse glioma
Boston, MA, Suresnes, France, February 20 2024– Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 20, 2024 Category: Drugs & Pharmacology Source Type: news

Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer
Application based on results from the TROPION-Lung01 Phase III trial If approved, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan may be the first TROP2-directed antibody drug conjugate for patients with lung cancer 19 February... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2024 Category: Drugs & Pharmacology Source Type: news

Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU
Zug, Switzerland– February 14, 2024– Galderma today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Applications for nemolizumab for the treatment of prurigo nodularis and for adolescents... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 14, 2024 Category: Drugs & Pharmacology Source Type: news

Citius Pharmaceuticals Resubmits the Biologics License Application of Lymphir (denileukin diftitox) for the Treatment of Adults With Relapsed or Refractory Cutaneous T-Cell Lymphoma
CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ( " Citius " or the " Company " ) (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 13, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Xspray Pharma ’s NDA-Resubmission for Dasynoc
Stockholm, Sweden– 2024-02-12 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY): The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc®, following a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 12, 2024 Category: Drugs & Pharmacology Source Type: news

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD
SAN JOSE, Calif., Feb. 9, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ( " Lykos " ), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration ( " FDA " ) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 9, 2024 Category: Drugs & Pharmacology Source Type: news

Amneal Announces Complete Response Resubmission for IPX203 New Drug Application
BRIDGEWATER, N.J., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the“Company”) today announced that it has provided a Complete Response resubmission to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 8, 2024 Category: Drugs & Pharmacology Source Type: news

Bridgebio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application Marketing Authorization Application accepted by the European Medicines... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 5, 2024 Category: Drugs & Pharmacology Source Type: news

Defender Pharmaceuticals Receives Complete Response Letter from the U.S. Food and Drug Administration for its Intranasal Scopolamine (DPI-386) New Drug Application for the Prevention of Nausea and Vomiting Induced by Motion in Adults
ST. LOUIS, MO—(BUSINESS WIRE)—Jan. 30, 2024—Defender Pharmaceuticals, Inc. (the“Company” or“Defender”), a privately held life sciences company based in St. Louis, today announced that the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 30, 2024 Category: Drugs & Pharmacology Source Type: news

Liquidia Corporation Provides Update on New Drug Application for Yutrepia (treprostinil) inhalation powder
MORRISVILLE, N.C., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) provided an update on its review of the New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 25, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Issues Complete Response Letter for Satsuma ’s STS101
TOKYO and KAGOSHIMA, Japan, January 18, 2024– Shin Nippon Biomedical Laboratories, Ltd. (TSE Prime: 2395, Chairman and President: Ryoichi Nagata, M.D., Ph.D.,“SNBL”) announced today that its wholly-owned US subsidiary, Satsuma... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 18, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Grants Soligenix Fast Track Designation for Dusquetide in the Treatment of Oral Lesions of Beh çet's Disease
PRINCETON, N.J., Jan. 8, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 8, 2024 Category: Drugs & Pharmacology Source Type: news

Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
TOKYO, Jan. 8, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, " Astellas " ) today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 8, 2024 Category: Drugs & Pharmacology Source Type: news