US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
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FDA Approves New Treatment for PNETs: What You Need to Know
The U.S Food & Drug Administration has granted approval for a targeted therapy called CABOMETYX ® to treat pancreatic ...
Wall Street Worries FDA Cuts Will Slow Drug Approvals
Steep cuts at the Food and Drug Administration might slow down drug approvals vital to the biopharma industry.
FDA approves cabozantinib for previously treated advanced neuroendocrine tumors
The U.S. Food and Drug Administration has approved cabozantinib (Cabometyx), an oral tyrosine kinase inhibitor, for patients ...
The US approved an Alzheimer’s drug. Seven patients subsequently died.
Leqembi — sold through a partnership between Eisai Co. and Cambridge-based Biogen — is one of the first medications approved ...
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FDA Approves Pluvicto for Earlier Use in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
The radioligand agent is now approved for use before chemotherapy in patients who have been treated with an androgen receptor pathway inhibitor.
US FDA greenlights GSK's drug for UTIs in women and girls
The U.S. Food and Drug Administration on Tuesday approved GSK's drug for a common type of urinary tract infection (UTI) in ...
FDA approves new drug to treat protein buildup in the heart
The FDA has approved a new drug for a serious heart condition that affects thousands of people. The drug, called Amvuttra ...
FDA approves first new antibiotic for UTIs in nearly 30 years
The drug Blujepa, from drugmaker GSK, provides a new treatment option as bacteria increasingly become resistant to the ...
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FDA Approves Fourth Denosumab Biosimilar
Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
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Qfitlia, a Novel Treatment for Hemophilia A or B, Gets FDA Approval
Fitusiran is a small interference RNA therapeutic designed to prevent bleeds in patients with hemophilia A or B by lowering antithrombin.
Biotech Investors Rush for the Exits After FDA Official Resigns
Biotech investors are reeling after the sudden departure of Peter Marks, a pivotal figure in the U.S. Food and Drug ...