Food and Drug Administration (FDA)
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The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations.
Badrul Chowdhury, director of the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER)’s Division of Pulmonary, Allergy and Rheumatology Products, has left the agency to take a position as senior vice president of research development at AstraZeneca and MedImmune.
It seems inevitable that as marijuana becomes more broadly legal in the U.S., that the biopharma industry and larger corporations will take an interest.
During a meeting with U.S. Food and Drug Administration Commissioner Scott Gottlieb earlier this week, government and healthcare officials in New Jersey highlighted the need to hasten the approval of new drugs and permanently eliminate the tax on medical devices.
Public health officials and scientists have had concerns about how long Ebola vaccines’ protection lasts. A new study shows that one of those vaccines confers at least two years of protection.
Utah’s Salt Lake County is the latest governing body to enter the legal battle against opioid manufacturers, distributors and prescribers. Governments are seeking financial restitution for the funds they have spent on battling addiction to prescription opioid medications.
The U.S. Food and Drug Administration (FDA) granted Genentech, a Roche company, Breakthrough Therapy Designation for Hemlibra (emicizumab-kxwh) for hemophilia A without factor VIII inhibitors.
Roche said it has gained 510(k) clearance from the U.S. Food and Drug Administration for cobas CT/NG for use on the cobas 6800/8800 Systems for the detection of chlamydia and gonorrhea in both symptomatic and asymptomatic patients.
The U.S. Food and Drug Administration (FDA) finalized two separate guidances for next-generation sequencing technologies.
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