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
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Wegovy Approved in the US for Cardiovascular Risk Reduction in People with Overweight or Obesity and Established Cardiovascular Disease
Bagsværd, Denmark, 8 March 2024– Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy based on a supplemental New Drug Application (sNDA) for the indication of reducing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 8, 2024 Category: Drugs & Pharmacology Source Type: news
MIDAC gives the nod to Lumicell ’s Lumisight
The Medical Imaging Drugs Advisory Committee (MIDAC) has voted in support of the benefit-risk profile of Lumisight.
During a March 5 meeting, MIDAC members voted 16 to 2 in favor of the company’s recent new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its Lumisight optical imaging agent for breast cancer and a premarket approval application (PMA) for the company's direct visualization system.
The company’s combined product is an intracavity, fluorescence-guided surgical imaging tool used to detect residual cancer in real-time during lumpectomy surgery, also known as breast-conserving surg...
Source: AuntMinnie.com Headlines - March 7, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Breast Imaging 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
SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN
STAMFORD, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has initiated a rolling... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 4, 2024 Category: Drugs & Pharmacology Source Type: news
Zevra Therapeutics Provides FDA Update On The PDUFA Action Date For Arimoclomol As A Treatment For Niemann-Pick Disease Type C
CELEBRATION, Fla., March 04, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has extended the review period... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 4, 2024 Category: Drugs & Pharmacology Source Type: news
Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia
NEW YORK, Feb. 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 medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 28, 2024 Category: Drugs & Pharmacology Source Type: news
Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2024 Category: Drugs & Pharmacology Source Type: news
BeiGene ’s Biologics License Application for Tevimbra (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA
BASEL, Switzerland& BEIJING& CAMBRIDGE, Mass.--(BUSINESS WIRE) February 27, 2024 -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2024 Category: Drugs & Pharmacology Source Type: news
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
FDA rejects Venatorx Pharmaceuticals' new drug application for flagship product
Founded in 2010, Venatorx Pharmaceuticals is backed by more than $120 million in financing. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 23, 2024 Category: Pharmaceuticals Authors: John George 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
