FDA Approves Lenmeldy (atidarsagene autotemcel) for Children with Metachromatic Leukodystrophy
TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 18, 2024 Category: Drugs & Pharmacology Source Type: news

CDER ’s Drug Quality Sampling and Testing Program
CDER ’s Office of Pharmaceutical Quality oversees the quality surveillance program using a targeted, risk-based approach to ensure the availability of safe, effective, quality drugs for the American public. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 18, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Adverse drug reactions from adrenaline auto-injectors: data from the French poison control centres - Pouessel G, Tournoud C, Gautier S, Nisse P, Tanno LK.
The current guidelines recommend adrenaline as first-line treatment for allergic emergencies.1 In France, adrenaline auto-injectors (AAI) are widely available in the community.2 In 2022, 965,944 AAI have been sold and four brands were commercialized with t... (Source: SafetyLit)
Source: SafetyLit - March 18, 2024 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

Remarks by Commissioner Robert M. Califf to the 2023 Global Summit on Regulatory Science - 09/26/2023
Remarks by Robert M. Califf, M.D. Commissioner of Food and Drugs 2023 Global Summit on Regulatory Science Sept. 26, 2023 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Xhance Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 15, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Roundup: March 15, 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 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

11th Annual Global Summit on Regulatory Science - 10/04/2021
Information about the Virtual 2021 Global Summit on Regulatory Science (GSRS21) - Title: 11th Annual Global Summit on Regulatory Science Conference (GSRS21); Theme: Regulatory Sciences for Food/Drug Safety with Real-World Data& Artificial Intelligence (AI); Question& Answer Sessions; October 4-6, 2021 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

PQRI Workshop:  Challenges and Opportunities for Modified Release Oral Drug Product Development - 04/18/2024
This PQRI Workshop will bring together leaders and subject matter experts from regulatory agencies, industry, and academia to discuss critical topics related to modified release (MR) drug products for oral administration. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Vi-Jon, LLC - 622087 - 03/08/2024
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop - 04/16/2024
PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Measles Control So Far in 2024:'Not Off to a Great Start'Measles Control So Far in 2024:'Not Off to a Great Start '
The recent rise in cases across the country is linked to unvaccinated travelers and lower-than-ideal vaccination rates, experts said.WebMD Health News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 15, 2024 Category: Drugs & Pharmacology Tags: Infectious Diseases Source Type: news

Drug Quality, Current Good Manufacturing Practice Inspections and Compliance
Hospitals, health systems and patients rely on FDA to ensure the medications that are available are safe, effective and of high quality. For application products, typically prescription drugs, FDA ’s approval process is the first step. FDA’s drug application approval includes assessing the manufactur (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Announces New Quality Oversight Webpage
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
CONSHOHOCKEN, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 14, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma
BASEL, Switzerland& BEIJING& CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 14, 2024 Category: Drugs & Pharmacology Source Type: news