Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally adva...
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients ...
(stem cell) transplant that uses donor stem cells (allogeneic).These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your health care provider will monitor you for these ...
(stem cell) transplant that uses donor stem cells (allogeneic).These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your health care provider will monitor you for these ...
Astellas Pharma Inc. and Seagen Inc. announced the U.S. Food and Drug Administration has granted PADCEV® with KEYTRUDA® accelerated approval in the U.S. as a combination therapy for the treatment o...
Approval for over-the-counter drugs can be done through an NDA or an OTC monograph. The FDA defines anOTC monographas a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which...
§ Keytruda (pembrolizumab), originally approved in 2014 to treat patients with advanced or unresectable melanoma who are no longer responding to other drugs. Throughout 2014 - 2017, it was approved for many new uses to treat patients with various forms of cancer. In May 2017, Keytruda was ap...
3、Therapy 11Priority Review11Accelerated Approval12Overall Use of Expedited Development and Review Methods 12Predictability:Meeting PDUFA Goals 13Access:First Cycle Approvals and First in US Approvals 14New Uses of Approved Drugs 16Approved Drugs Expanded for New Pediatric Populations 18Biosimilar App ...
3、er Countries.24New and Expanded Uses of Already FDA-Approved Drugs .26New Uses .26New Populations.32Additional Approvals .34Biosimilars.34New Formulations and Other Notable Approvals .35New Dosage Forms.36Conclusion.38Patrizia Cavazzoni,M.D.Acting Director,Center for Drug Evaluation and Research...
More from the Alliance for a Stronger FDA on the potential new funding’s uses here. If a deal isn’t reached, FDA is likely to face another continuing resolution at fiscal 2018 funding levels. Congress could pass a short-term CR and let the new Congress handle the spending fights early ...