FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patients
Toronto, Ontario and Chicago, Illinois-- March 26, 2024 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus ' s supplemental Biologics License Application (sBLA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Roundup: March 26, 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 - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects
FDA warns consumers not to use certain over-the-counter pain relief products containing lidocaine that are marketed for topical use in cosmetic procedures like microdermabrasion, laser hair removal, tattooing and piercing, and issued warning letters to six companies for violating of federal law. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Indelicare DBA INKEEZE - 671656 - 03/25/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
TKTX Company - 673879 - 03/25/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
SeeNext Venture, Ltd. - 674915 - 03/25/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Dermal Source, Inc. - 663632 - 03/25/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Tattoo Numbing Cream Co. - 672467 - 03/25/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Sky Bank Media, LLC dba Painless Tattoo Cream Co. - 666693 - 03/25/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples
Guidance for Industry - Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples, Generics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
An Update on Sunscreen Requirements: The Deemed Final Order and the Proposed Order
FDA is posting the deemed final order for over-the-counter (OTC) sunscreens and is issuing a proposed order for sunscreens. This explains today ’s activities and what the orders mean for consumers, health care providers, industry, and other stakeholders. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Real World Evidence - From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies
Real World Evidence --- From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies with Jacqueline Corrigan-Curay and David Martin (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA 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
Bret R. Rutherford, M.D. - 670544 - 03/21/2024
Clinical Investigator (Sponsor) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 25, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
