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The FDA has approved Bristol Myers Squibb (BMS)’s Opdivo (nivolumab) in combination with chemotherapy as a first-line treatment for patients with gastric and esophageal cancers. Read More
The Centers for Disease Control and Prevention (CDC) will convene a second emergency meeting of its Advisory Committee on Immunization Practices at the end of the week to discuss the use of Johnson & Johnson (J&J)’s COVID-19 vaccine, following a delayed vote at its initial discussion on cases of very rare blood clots seen in vaccinated patients. Read More
The Indian government and the Russian Direct Investment Fund reached an agreement that will allow Indian companies to produce 850 million doses of the vaccine per year. Read More
The agency said it does not believe that the drug’s pharmacokinetic profile is comparable to the manufactured drug used by Eli Lilly when it was researching it more than a decade ago. Read More
The FDA granted the approval based on progression-free survival and overall survival rates from studies of cancer patients and real-world data. Read More
The FDA has approved a new, biweekly dosing regimen for ImClone’s cancer drug, Erbitux (cetuximab), for patients with a certain form of EGFR-expressing colorectal cancer or head and neck squamous-cell carcinoma. Read More