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
Lumicell's Lumisight, LumiSytem get FDA nods
Lumicell's Lumisight (pegulicianine) optical imaging agent has been approved by a new drug application (NDA) by the U.S. Food and Drug Administration (FDA).
The FDA has also granted premarket approval for the company's LumiSystem, Lumicell's direct visualization system. Both Lumisight and LumiSystem previously received FDA Fast Track and Breakthrough Device designations.
LumiSystem allows surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries. Its combination with Lumisight is indi...
Source: AuntMinnie.com Headlines - April 18, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news
PET tracer for gliomas under expedited review
The U.S. Food and Drug Administration (FDA) has granted fast-track designation to Telix Pharmaceuticals’ PET radiotracer F-18 floretyrosine (Pixclara) for imaging progressive or recurring gliomas.
Pixclara was developed by researchers at the University of California, San Francisco. The tracer reveals the activity of specific transporter proteins known as LAT1 and LAT2, which are highly active in brain regions with gliomas. The technique can help determine if a glioma is truly progressing or undergoing a treatment-induced change, known as pseudo-progression, where standard MRI is often inconclusive, the company said.
Pi...
Source: AuntMinnie.com Headlines - April 17, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Molecular Imaging 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
FDA Expands Indication for Gilead's Vemlidy (tenofovir alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six
March 28, 2024 -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 28, 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
Lumicell touts Lumisight clinical results
Lumicell highlighted clinical results presented at the recent Society of Surgical Oncology (SSO) in Atlanta, GA, that it says demonstrate the benefits of its Lumisight optical imaging agent for breast cancer.
In 2023, the company submitted a new drug application (NDA) for Lumisight for use in patients with breast cancer undergoing a lumpectomy, along with a premarket approval (PMA) application for its Direct Visualization System (DVS). On March 5, the U.S. Food and Drug Administration's (FDA) Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of Lumisight's benefit-risk profile, according to the firm. (S...
Source: AuntMinnie.com Headlines - March 25, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news
