June 18, 2024
The US Food and Drug Administration approved blinatumomab (Blincyto — Amgen) as consolidation for CD19-positive, Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in both children […]
June 18, 2024
In the field of allergology, desensitization to animals, specifically cats, is rarely prescribed. Has allergen immunotherapy (IT), which has long been considered ineffective, evolved? What other […]
June 17, 2024
FDA considers advancing the availability of evidence-based guidelines for opioid analgesics and other medications with abuse potential a high-impact opportunity to support the safe use of […]
June 17, 2024
Share on PinterestWNBA legend Diana Taurasi (above) is sharing how she learned to manage painful eczema flair-ups. Photography courtesy of Sanofi Regeneron WNBA legend Diana Taurasi […]
June 17, 2024
IMPACT INNOVATION PREDICTABILITY ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2021 Director’s Message Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) annual report, […]
June 17, 2024
On This Page Date: July 23, 2024 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR (Hosted […]
June 17, 2024
On average, FDA determines that the vast majority of all expanded access requests may proceed. Sometimes called “compassionate use”, expanded access is a potential pathway for […]
June 17, 2024
For Post-Marketing Reports Drugs: FDA required that applicants electronically submit all ICSRs, ICSR attachments, and periodic safety reports. Refer to FDA Adverse Events Reporting System (FAERS) […]
June 17, 2024
On this page, you will find information about: What is expanded access? Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious […]
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