April 4, 2023

FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19

[4/4/2023] FDA has issued an emergency use authorization (EUA) for the use of Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated […]
April 3, 2023

FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma

On April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally […]
April 3, 2023

Episciences Inc. – 631902 – 08/25/2022

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Chad M. Thayer Recipient Title Chief Operating Officer Episciences Inc. 10211 West Emerald StreetBoise, […]
April 3, 2023

Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products – 06/15/2023

On This Page Date: June 15, 2023 Time: 8:30 AM – 5:30 PM ET Registration Information: Register Now About the Event: The presence of N-nitrosamines in […]
April 3, 2023

A Deep Dive: GDUFA III Scientific Meetings – 05/15/2023

On This Page Date: May 15, 2023 Time: 1:00 PM – 4:30 PM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR […]
April 3, 2023

Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development 

A biosimilar product (biosimilar) is highly similar to, and has no clinically meaningful differences from, an FDA-approved reference product. Biosimilars may spur competition and result in […]
March 31, 2023

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product

Summary Company Announcement Date: March 13, 2023 FDA Publish Date: March 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Bacillus cereus Contamination […]
March 31, 2023

Drug Disposal: Questions and Answers

FDA is aware of reports of very low, but measurable levels of medicines in surface waters such as rivers and streams, and to a lesser extent […]
March 31, 2023

Identification of Medicinal Products — Implementation and Use

Docket Number: FDA-2023-D-0266 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is for sponsors, applicants, […]
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