Abeona Therapeutics Provides Regulatory Update on Pz-cel
CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 22, 2024 Category: Drugs & Pharmacology Source Type: news
Supernus Provides Regulatory Update for SPN-830
ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 8, 2024 Category: Drugs & Pharmacology Source Type: news
Stealth Biotherapeutics Announces FDA Acceptance of New Drug Application for Elamipretide for the Treatment of Barth Syndrome
NEEDHAM, Mass., April 8, 2024 /PRNewswire/— Stealth BioTherapeutics, a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 8, 2024 Category: Drugs & Pharmacology Source Type: news
Jazz Pharmaceuticals Completes Zanidatamab Biologics License Application for Previously Treated HER2-Positive Metastatic Biliary Tract Cancer
DUBLIN, April 2, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 2, 2024 Category: Drugs & Pharmacology Source Type: news
Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer
2 April 2024 -- AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 2, 2024 Category: Drugs & Pharmacology Source Type: news
Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia
MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 28, 2024 Category: Drugs & Pharmacology Source Type: news
Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease
LEXINGTON, Mass.--(BUSINESS WIRE)--Mar. 28, 2024-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 28, 2024 Category: Drugs & Pharmacology Source Type: news
Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
NEW YORK, March 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 28, 2024 Category: Drugs & Pharmacology Source Type: news
Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia
WALTHAM, Mass., March 26, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 26, 2024 Category: Drugs & Pharmacology Source Type: news
IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick Disease Type C
March 26, 2024 -- IntraBio Inc today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for IB1001 for the treatment of Niemann-Pick disease Type C (NPC).
The application has been granted Priority... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 26, 2024 Category: Drugs & Pharmacology Source Type: news
Regeneron Provides Update on Biologics License Application for Odronextamab
TARRYTOWN, N.Y., March 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 25, 2024 Category: Drugs & Pharmacology Source Type: news
PTC Therapeutics Announces the Submission of a BLA to the U.S. FDA for Upstaza (eladocagene exuparvovec) for the Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency
SOUTH PLAINFIELD, N.J., March 19, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the submission of a BLA to the U.S. FDA for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of aromatic L-amino... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 19, 2024 Category: Drugs & Pharmacology Source Type: news
Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or“the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 18, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib
MIAMI--(BUSINESS WIRE) March 13, 2024 --Xcovery Holdings, Inc., an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 13, 2024 Category: Drugs & Pharmacology Source Type: news
Lumicell Announces FDA Advisory Committee ’s Positive Recommendation on the Benefit-Risk Profile of Lumisight in the Detection of Cancerous Tissue During Breast Conserving Surgery
NEWTON, Massachusetts March 6, 2024– Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer, today announced the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 6, 2024 Category: Drugs & Pharmacology Source Type: news
