The June meeting was scheduled after expedited approval was denied. The Food and Drug Administration (FDA) announced this week that it has scheduled a meeting of the Peripheral…
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FDA Approves Duchenne Muscular Dystrophy Treatment for Children
Duvyzat receives approval under fast-track designation. The U.S. Food and Drug Administration (FDA) has approved Duvyzat (givinostat) as an oral medication for the treatment of Duchenne Muscular Dystrophy…
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FDA Warns Against Over-the-Counter Pain Relief Products for Cosmetic Procedures
Six companies receive warning letters as the FDA addresses unsafe topical analgesics and urges consumer vigilance. The U.S. Food and Drug Administration (FDA) has cautioned against using specific…
Read MoreFDA Approves Medication for Liver Scarring
The medication was fast-tracked through the agency’s accelerated approval pathway. The U.S. Food and Drug Administration (FDA) has authorized Rezdiffra (resmetirom) for adults experiencing noncirrhotic non-alcoholic steatohepatitis (NASH),…
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Tricare Prescription Coverage Still Hampered by Change Healthcare Hack
Many military families are paying full price for medications. The cyberattack against Change Healthcare a month ago has impacted the military’s Tricare network of pharmacies. Change Healthcare is…
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FDA Approves Wegovy for Cardiovascular Risk Reduction
The injection becomes the first weight loss medication to address life-threatening cardiovascular events. The Food and Drug Administration has expanded the approved use of Wegovy (semaglutide) injection, making…
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HHS Issues Letter to Healthcare Officials on Cyberattack
The agency outlines the steps being taken after the Change Healthcare ransomware incident. The Department of Health and Human Services released a letter to health professionals over the…
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Drug Companies Submit Counteroffers in Pricing Negotiation
President says Medicare continues negotiating drug prices to reduce costs. President Joe Biden reported that drugmakers have submitted counteroffers this week for Medicare’s new price negotiation program, beginning…
Read MoreFDA Approves Cellular Therapy for Advanced Melanoma
Approval provides early access to therapy while clinical trials continue. The U.S. Food and Drug Administration (FDA) recently approved Amtagvi (lifileucel) as the first cellular therapy for adults…
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FDA Finding Prompts Recall of Eye Ointment Products
The agency reported one of the products lacked the assurance of sterility. The Food and Drug Administration (FDA) issued an announcement this week that four types of eye…
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