FDA Center for Drug Evaluation and Research - What's New 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.FDA Approves New Treatment for Uncomplicated Urinary Tract Infections
Today, the FDA approved a new treatment for female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 24, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: April 23, 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 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma
On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutati (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
2023 Warning Letters - Health Fraud
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
2022 Warning Letters - Health Fraud
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Dr. Reddy ’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as"Dr. Reddy's"), today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer leve (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS
On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NE (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
STOP CLOPEZ CORP Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil
Hollywood, FL, US, STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products to contain Nortadalafil. Nortadalafil is an active drug ingredient known for the treatment of male erectile dysfunction. The presence of Nor (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites - 06/13/2024
OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Stop - Learn - Go: Tips for Talking with Your Pharmacist to Learn How to Use Medicines Safely
Points to discuss with your pharmacist and other healthcare providers (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Zen Enterprises LLC - 678407 - 04/18/2024
Failure to Register and List (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Dr Sankunni ’s Ayurvedic Research Foundation Private Ltd. - 678046 - 04/18/2024
Failure to Register and List (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Reflections on Travel to Europe – Part Three
I recently had the privilege of official travel to the European Union with our global affairs team. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Gu érin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papilla (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
2024 Compounding Quality Center of Excellence Annual Conference - 08/21/2024
The FDA Compounding Quality Center of Excellence will host its fifth Annual Conference, Aug. 21-23. This hybrid event provides an opportunity for outsourcing facilities and others to learn and build networks to help the industry improve the quality of compounded drugs for patients who need them. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
