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
Regulatory Education for Industry (REdI) Annual Conference 2024: Biologics Track
The Biologics Track will focus on the developmental and regulatory topics relevant to cellular and gene therapies, tissue-engineered products, blood products, vaccines, and other biological products. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Regulatory Education for Industry (REdI) Annual Conference 2024: Devices Track
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Regulatory Education for Industry (REdI) Annual Conference 2024: Drugs Track
The drugs track will address major advances and innovation across various aspects of the drug development spectrum. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development - 05/29/2024
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 8, 2024 Category: Drugs & Pharmacology Authors: FDA 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
Enhertu Approved in the US as First Tumor-Agnostic HER2-Directed Therapy for Previously Treated Patients with Metastatic HER2-Positive Solid Tumors
April 6, 2024 -- AstraZeneca and Daiichi Sankyo ' s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 2024 Category: Drugs & Pharmacology Source Type: news
Quality Metrics for Drug Manufacturing
Quality Metrics Data Reporting: This program will help FDA to address common quality issues in the pharmaceutical industry, address product shortage issues, and encourage modernization of pharmaceutical manufacturing. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: April 5, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Ivermectin and COVID-19
There continues to be interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Aruba Aloe Balm N.V. Issues Voluntary Nationwide Recall of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel Due to Presence of Methanol
Oranjestad, Aruba, Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel to the consumer level. The products have been found to contain alcohol denatured with methanol. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Honeywell Safety Products USA, Inc. Issues Voluntary Worldwide Recall of Honeywell Fendall 2000 Non-Sterile Eyewash Cartridges # 32-002050-0000 used with the Fendall 2000 Eyewash Station Due to a Lack of Appropriate Policies and Procedures by Honeywell ’s Supplier
Charlotte, NC, Honeywell Safety Products USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station. This recall is being conducted at the industrial consumer level. Honeywell ’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has bee (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Lead's Lingering Threat: Water and More Pose Dangers Lead's Lingering Threat: Water and More Pose Dangers
New studies reveal lead in drinking water is still a problem, and clinicians may want to screen children for lead exposure.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 5, 2024 Category: Drugs & Pharmacology Tags: Family Medicine/Primary Care Source Type: news
FDA Approves Carvykti for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy
HORSHAM, PA (April 5, 2024)– Johnson& Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved Carvykti® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 5, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
PRINCETON, N.J.,& CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2024 -- Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 5, 2024 Category: Drugs & Pharmacology Source Type: news
