The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 9, 2024. The sBLA is based on data from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in a research collaboration with Seagen and Astellas, in which KEYTRUDA plus...
When surgery is required, importance of informing the attending physician, dentist, or anesthesiologist of recent (within 12 months) glucocorticoid therapy. In immunosuppressed patients, importance of avoiding exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining...
The choice of treatment for non-small cell lung cancer depends on its stage at the time of diagnosis. Surgery to remove the cancerous portion may be the only treatment required for some people with NSCLC stage I. Most people, however, need a combination of different therapies. Early detection...
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under acceler...
State opioid assessments related to prior fiscal years is the portion of state assessments for prescription opioid medications that were sold or distributed in periods prior to the period in which the expense is incurred. This portion is excluded from ...
The resulting number is communicated as mutations per Mb unit (mut/Mb). Per the F1CDx assay, a patient whose tumor has a TMB ≥ 10 mut/Mb is reported as eligible for treatment with KEYTRUDA: After completion of the Analysis Pipeline, variant data are displayed in the FMI custom-developed...
Alternatively or additionally, other carriers can be employed, if required. Liposomes and emulsions are well known examples of delivery vehicles or carriers for hydrophobic drugs and drug compositions. Additionally, a composition described herein can be delivered using a sustained-release system, such as...
People with aggressive forms of breast, lung and prostate cancer have been offered a lifeline in recent years as new treatments hit the market including AstraZeneca’s Enhertu, Merck’s Keytruda and Novartis’s Pluvicto. But a new weapon to fight pancreatic cancer, the deadliest common form ...
Annalee Armstrong Legal Novo Enters the Ring in Legal Fight Against GLP-1 Compounders as Lilly Notches Victory March 6, 2025 · 3 min read · Kate Goodwin Patents Merck’s Injectable Keytruda Plans Create Legal Dispute Wit...