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…
Read MoreFood and Drug Administration
FDA Approves Treatment for Uncomplicated UTIs
The medication, Pivya, is now an option for women with uncomplicated urinary tract infections. The Food and Drug Administration (FDA) approved Pivya tablets for treating uncomplicated urinary tract…
Read More
HHS Postpones Menthol Cigarette Ban
Public health advocates question the delay and civil rights groups are concerned with minority health. The Department of Health and Human Services (HHS) recently moved back the implementation…
Read More
Federal Court Places Injunction Over Sleep Therapy Device Safety Concern
Consent decree mandates remediation plan following worldwide recall, FDA oversight ensures patient safety and compliance The District Court for the Western District of Pennsylvania issued a permanent injunction…
Read More
Biotech CEO Sentenced for Obstructing Investigation of Fake COVID-19 Tests
Keith Berman defrauded medical device investors and lied to the FDA. The CEO of a fraudulent California biotechnology company was sentenced to seven years of prison on Friday…
Read More
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…
Read More
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),…
Read More
Supreme Court Hears Medication Abortion Case
Mifepristone is a prescription drug used in medication abortions that can sent via the mail. The Supreme Court heard initial arguments for the restriction of mifepristone, a prescription…
Read More
Prosecutors Investigate Meta For Possible Involvement in Illegal Drug Sales
FDA assists in the review of records from the social media company. Federal prosecutors have begun a probe into Facebook’s parent company, Meta, to determine whether its social…
Read More