Drug Approvals and Databases | FDA - U.S. Food and Drug …
CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Additional topics include: approved ...
Development & Approval Process | Drugs | FDA
FDA Approval: What it means. FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and ...
Approvals of FDA-Regulated Products
Approval information by product type Drugs. Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes)
Learn About Drug and Device Approvals | FDA
From concept to approval and beyond, FDA: Reviews research data and information about drugs and devices before they become available to the public. Watches for drug problems once drugs and devices ...
Device Approvals and Clearances | FDA
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that ...
FDA approves axatilimab-csfr for chronic graft-versus-host disease
2024年8月14日 · Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
FDA approves revumenib for relapsed or refractory acute leukemia
On November 15, 2024, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.) for relapsed or refractory acute leukemia with a KMT2A translocation.
FDA approves obecabtagene autoleucel for acute lymphoblastic …
On November 8, 2024, the FDA approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.) for relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
FDA approves first treatment for adults with complement 3 ...
2025年3月20日 · FDA first approved Fabhalta in 2023 for the treatment of adults with paroxysmal nocturnal hemoglobinuria. It is also approved under accelerated approval for the reduction of proteinuria in adults ...
FDA Roundup: March 4, 2025
2025年3月4日 · Anticoagulants (blood thinners) are among the most commonly prescribed medications in the U.S., and Monday’s approval of the first generics of rivaroxaban, 2.5 mg, tablets will make a direct ...